T & L SHARPENING, INC.
Registration 3003541440FEI 3003541440Indiana Beach, IN
Owner/operator: T & L SHARPENING, 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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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 32
- Added, last 12 months
- 17
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 32
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KWP | Appliance, Fixation, Spinal InterlaminalOrthopedic | Class 2 | 21 CFR 888.3050 | — |
| KWQ | Appliance, Fixation, Spinal Intervertebral BodyOrthopedic | Class 2 | 21 CFR 888.3060 | — |
| JDO | Device, Fixation, Proximal Femoral, ImplantOrthopedicAdded Mar 10, 2026 | Class 2 | 21 CFR 888.3030 | — |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedicAdded Mar 10, 2026 | Class 2 | 21 CFR 888.3358 | — |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedicAdded Mar 10, 2026 | Class 2 | 21 CFR 888.3353 | — |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, CementedOrthopedicAdded Mar 10, 2026 | Class 2 | 21 CFR 888.3350 | — |
| JDS | Nail, Fixation, BoneOrthopedic | Class 2 | 21 CFR 888.3030 | — |
| OLO | Orthopedic Stereotaxic InstrumentNeurology | Class 2 | 21 CFR 882.4560 | — |
| MNI | Orthosis, Spinal Pedicle FixationOrthopedicAdded Mar 10, 2026 | Class 2 | 21 CFR 888.3070 | — |
| MNH | Orthosis, Spondylolisthesis Spinal FixationOrthopedicAdded Mar 10, 2026 | Class 2 | 21 CFR 888.3070 | — |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedicAdded Mar 10, 2026 | Class 2 | 21 CFR 888.3070 | — |
| HRS | Plate, Fixation, BoneOrthopedic | Class 2 | 21 CFR 888.3030 | — |
and 20 more on your full dossier
What changed
- Mar 10, 2026Listing added: JDO — Device, Fixation, Proximal Femoral, Implant
- Mar 10, 2026Listing added: OQG — Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- Mar 10, 2026Listing added: OQI — Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- Mar 10, 2026Listing added: OQH — Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
- Mar 10, 2026Listing added: MNI — Orthosis, Spinal Pedicle Fixation
- Mar 10, 2026Listing added: MNH — Orthosis, Spondylolisthesis Spinal Fixation
- Mar 10, 2026Listing added: OSH — Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- Mar 10, 2026Listing added: MAY — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- Mar 10, 2026Listing added: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Mar 10, 2026Listing added: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Mar 10, 2026Listing added: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Mar 10, 2026Listing added: LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Mar 10, 2026Listing added: MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Mar 10, 2026Listing added: HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Mar 10, 2026Listing added: MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Mar 10, 2026Listing added: OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- Mar 10, 2026Listing added: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer