INTELIVATION TECHNOLOGIES, LLC
Registration 3019356409FEI 3019356409Plymouth Meeting, PA
Owner/operator: Intelivation Technologies LLC.
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Repack or Relabel Medical Device
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 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 27
- Added, last 12 months
- 7
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 27
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| ODP | Advantage-C PEEK Cervical Interbody Fusion DeviceIntervertebral Fusion Device With Bone Graft, Cervical | Class 2 | 21 CFR 888.3080 | K211501 |
| MAX | Advantage Lumbar- ALIF, PLIF, DLIF, TLIFIntervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | 21 CFR 888.3080 | K212389 |
| HTY | Hammerdesis Interphalangeal Fusion SystemPin, Fixation, Smooth | Class 2 | 21 CFR 888.3040 | K231147 |
| JDW | Hammerdesis Interphalangeal Fusion SystemPin, Fixation, Threaded | Class 2 | 21 CFR 888.3040 | K231147 |
| JDR | TruTrack MEM STAPLE 11X15X13-1.5X1.5MM PKGStaple, Fixation, Bone | Class 2 | 21 CFR 888.3030 | K061798 |
| NKB | Golden Isles Pedicle Screw SystemThoracolumbosacral Pedicle Screw System | Class 2 | 21 CFR 888.3070 | K212185 |
| HWJ | TruTrackAwl | Class 1 | 21 CFR 888.4540 | — |
| HXW | Golden Isles Pedicle Screw SystemBender | Class 1 | 21 CFR 888.4540 | — |
| HTW | Advantage-LUMBARD Interbody Disc DrillBit, Drill | Class 1 | 21 CFR 888.4540 | — |
| GES | AOL-200 Advantage Lumbar Expandable Disc ShaverBlade, Scalpel | Class 1 | 21 CFR 878.4800 | — |
| KTZ | Rod Measurement CaliperCaliperAdded Jan 6, 2026 | Class 1 | 21 CFR 888.4150 | — |
| HWR | TruTrack Staple InserterDriver, Prosthesis | Class 1 | 21 CFR 888.4540 | — |
and 15 more on your full dossier
What changed
- Jan 6, 2026Listing added: KTZ — Rod Measurement Caliper
- Jan 6, 2026Listing added: HTJ — Screw Depth Measuring Instrument
- Jan 6, 2026Listing added: HWA — Impaction Cap
- Jan 6, 2026Listing added: HWN — MIS Compressor
- Mar 23, 2026Listing added: HXB — Sounder Probe, Curved
- Jan 28, 2026Listing added: HTO — Hole Reamer, Large
- Mar 23, 2026Listing added: HWX — Tap, Double Lead, 4.5mm