Identity
- Trade Name
- PolyLock Ankle FDA UDI
- Generic Name
- Bone fixation plate pliers FDA UDI
- Device Name
- Plate Bending Pliers FDA UDI
- Model / Reference
- TN-AK-0004 FDA UDI
- Description
- Plate Bending Pliers FDA UDI
Identifiers
- Catalog Number
- TN-AK-0004 FDA UDI
- Primary DI / UDI-DI
- 00840124520318 FDA UDI
- 510(k) Number
- K211843 FDA UDI
- FDA Product Code
- HTC FDA UDI
- GMDN Term
- Bone fixation plate pliers FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone fixation plate pliers
PolyLock Ankle by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone fixation plate pliers.
- PLIERS — KLS-Martin L.P. · Class I
- LEVEL ONE — KLS-Martin L.P. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- VARIAX — Stryker Corp. · Class I
- Evos Mini — Smith & Nephew, Inc. · Class I
- Surgical Instrument — Jeil Medical Corporation · Class I
- LEVEL ONE — KLS-Martin L.P. · Class I
- Bioplate® — Bioplate, Inc. · Class I
Cleared under the same submission
K211843 also covers:
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- LapiLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI a8128cd8-6a60-4127-9838-3ca7b2e286c0 35 fields · synced Jun 1, 2026