Identity
- Trade Name
- PolyLock Ankle FDA UDI
- Generic Name
- Orthopaedic bone fixation plate spacer FDA UDI
- Device Name
- Hintermann Distractor 15cm FDA UDI
- Model / Reference
- TN-AK-0006 FDA UDI
- Description
- Hintermann Distractor 15cm FDA UDI
Identifiers
- Catalog Number
- TN-AK-0006 FDA UDI
- Primary DI / UDI-DI
- 00840124520981 FDA UDI
- 510(k) Number
- K211843 FDA UDI
- FDA Product Code
- PLF FDA UDI
- GMDN Term
- Orthopaedic bone fixation plate spacer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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 bone fixation plate spacer
PolyLock Ankle by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone fixation plate spacer.
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- Joint Shim — Medshape, Inc. · Class I
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- GSO GS1 Spacer — UNIFIED SPINE, LLC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI 40b8a498-d58e-4602-9a27-d79cf601d30f 35 fields · synced Jun 1, 2026