Identity
- Trade Name
- PolyLock Midfoot FDA UDI
- Generic Name
- Orthopaedic implant aiming arm FDA UDI
- Device Name
- LapiForm Jig Left FDA UDI
- Model / Reference
- TN-LF-9003 FDA UDI
- Description
- LapiForm Jig Left FDA UDI
Identifiers
- Catalog Number
- TN-LF-9003 FDA UDI
- Primary DI / UDI-DI
- 00840124521032 FDA UDI
- 510(k) Number
- K211843 FDA UDI
- FDA Product Code
- NNO FDA UDI
- GMDN Term
- Orthopaedic implant aiming arm FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3540 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: Orthopaedic implant aiming arm
PolyLock Midfoot by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant aiming arm.
- ANTEGRADE TARGETING MODULE FEMORAL NAIL SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
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- ANTEGRADE FEMORAL NAIL DRIVER — Biomet Orthopedics, Inc. · Class I
- Jig — I.T.S. GmbH · Class I
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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 |
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Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI d01f57f3-b388-455a-9787-6f9468f14a8a 35 fields · synced Jun 8, 2026