LISI MEDICAL Remmele
Registration 3000203391FEI 3000203391Coon Rapids, MN
Owner/operator: Precera Medical Inc
- Manufacture Medical Device for Another Party (Contract Manufacturer)
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- Dec 23Holiday week8 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 59
- Added, last 12 months
- 59
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 59
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| NHA | Zimmer Contour Restorative SystemAbutment, Implant, Dental, EndosseousAdded Dec 5, 2025 | Class 2 | 21 CFR 872.3630 | — |
| KWP | NUT LOCKING TRANS CONN SILHAppliance, Fixation, Spinal InterlaminalAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3050 | — |
| KWP | KodiakAppliance, Fixation, Spinal InterlaminalAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3050 | — |
| KWP | Appliance, Fixation, Spinal InterlaminalOrthopedicAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3050 | — |
| KWP | APPLIANCE, FIXATIONAppliance, Fixation, Spinal InterlaminalAdded May 7, 2026 | Class 2 | 21 CFR 888.3050 | — |
| KWP | CURVED ROD PKGED ST360Appliance, Fixation, Spinal InterlaminalAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3050 | — |
| KWP | ROOK, OCC. SCREWAppliance, Fixation, Spinal InterlaminalAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3050 | — |
| KWP | ArsenalAppliance, Fixation, Spinal InterlaminalAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3050 | — |
| KWQ | Insignia ScrewAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3060 | — |
| KWQ | TRINICA IMP PLATE CERVICAL NSAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3060 | — |
| KWQ | InsigniaAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3060 | — |
| KWQ | V2F PLTEAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 5, 2025 | Class 2 | 21 CFR 888.3060 | — |
and 47 more on your full dossier
What changed
- Dec 5, 2025Listing added: NHA — Zimmer Contour Restorative System
- Dec 5, 2025Listing added: KWP — NUT LOCKING TRANS CONN SILH
- Dec 5, 2025Listing added: KWP — Kodiak
- Dec 5, 2025Listing added: KWP — Appliance, Fixation, Spinal Interlaminal
- May 7, 2026Listing added: KWP — APPLIANCE, FIXATION
- Dec 5, 2025Listing added: KWP — CURVED ROD PKGED ST360
- Dec 5, 2025Listing added: KWP — ROOK, OCC. SCREW
- Dec 5, 2025Listing added: KWP — Arsenal
- Dec 5, 2025Listing added: KWQ — Insignia Screw
- Dec 5, 2025Listing added: KWQ — TRINICA IMP PLATE CERVICAL NS
- Dec 5, 2025Listing added: KWQ — Insignia
- Dec 5, 2025Listing added: KWQ — V2F PLTE
- May 7, 2026Listing added: KWQ — APPLIANCE, FIXATION
- Dec 5, 2025Listing added: KWQ — InViZia (Anterior Cervical Plate Sys)
- Dec 5, 2025Listing added: KWQ — ALP, SRW FXD TRINICA
- Dec 5, 2025Listing added: KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Dec 5, 2025Listing added: GZL — ELECTRODE, DEPTH
- Dec 5, 2025Listing added: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Dec 5, 2025Listing added: DZE — Spline Dental Implant System
- Dec 5, 2025Listing added: DZE — Screw-Vent Dental Implant System
- Dec 5, 2025Listing added: DZE — Implant, Endosseous, Root-Form
- Dec 5, 2025Listing added: MAX — Asfora Bullet Cage® (System)
- Dec 5, 2025Listing added: OVE — Interfixated Screw
- Dec 5, 2025Listing added: OTN — ArcTV Transvaginal Sling System
- Dec 5, 2025Listing added: OTN — ArcSP Suprapubic Sling System
- Dec 5, 2025Listing added: MNI — Arsenal
- Dec 5, 2025Listing added: MNI — CNNLTD PLYSCRW
- Dec 5, 2025Listing added: MNI — CURVED ROD PKGED ST360
- Dec 5, 2025Listing added: MNI — NUT LOCKING TRANS CONN SILH
- Dec 5, 2025Listing added: MNI — ARSENAL SPINAL FIXATION SYSTEM
- Dec 5, 2025Listing added: MNI — SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
- Dec 5, 2025Listing added: MNI — Orthosis, Spinal Pedicle Fixation
- Dec 5, 2025Listing added: MNH — CNNLTD PLYSCRW
- Dec 5, 2025Listing added: MNH — Arsenal
- Dec 5, 2025Listing added: MNH — CURVED ROD PKGED ST360
- Dec 5, 2025Listing added: MNH — NUT LOCKING TRANS CONN SILH
- Dec 5, 2025Listing added: MNH — ARSENAL SPINAL FIXATION SYSTEM
- Dec 5, 2025Listing added: MNH — SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
- Dec 5, 2025Listing added: OSH — ARSENAL SPINAL FIXATION SYSTEM
- Dec 5, 2025Listing added: OSH — Arsenal
- Dec 5, 2025Listing added: OUR — SAMBA Screw (System)
- Dec 5, 2025Listing added: HWC — SAMBA Screw (System)
- Dec 5, 2025Listing added: HWC — Fixation screw
- Dec 5, 2025Listing added: HWC — Screw, Fixation, Bone
- Dec 5, 2025Listing added: JDR — Staple, Fixation, Bone
- Dec 5, 2025Listing added: NKB — Kodiak
- Dec 5, 2025Listing added: NKB — ARSENAL SPINAL FIXATION SYSTEM
- May 7, 2026Listing added: NKB — APPLIANCE, FIXATION
- Dec 5, 2025Listing added: NKB — SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
- Dec 5, 2025Listing added: NKB — CURVED ROD PKGED ST360
- Dec 5, 2025Listing added: NKB — Modular Polyaxial Tulip
- Dec 5, 2025Listing added: NKB — Thoracolumbosacral Pedicle Screw System
- Dec 5, 2025Listing added: NKB — Arsenal
- Dec 5, 2025Listing added: NKB — CNNLTD PLYSCRW
- Dec 5, 2025Listing added: NDP — Accessories, Implant, Dental, Endosseous
- Dec 5, 2025Listing added: DZA — Surgical Drill System
- Dec 5, 2025Listing added: GFC — PIN INTERNAL INSERTION DISPOSABLE TRINICA
- Dec 5, 2025Listing added: LXH — Trinica & Trinica Select
- Dec 5, 2025Listing added: MRW — FACET screw