Identity
- Trade Name
- PolyLock Ankle Plates FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Utility Straight Plate 8 Hole FDA UDI
- Model / Reference
- AK-UP-0008 FDA UDI
- Description
- Utility Straight Plate 8 Hole FDA UDI
Identifiers
- Catalog Number
- AK-UP-0008 FDA UDI
- Primary DI / UDI-DI
- 00840124505506 FDA UDI
- 510(k) Number
- K202959 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile 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
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 fixation plate, non-bioabsorbable, non-sterile
The PolyLock Ankle Plates are a non-bioabsorbable, non-sterile orthopedic fixation plate designed for the treatment of traumatic or pathological fractures in long bones. This device is typically used to stabilize fracture gaps and shield the site from stress as bone heals.
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
- CANNULATED SCREW SYSTEM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Proximal Humeral Locking Plate Ⅱ, Combi-holes — Double Medical Technology Inc. · Class II
- ORTHOLOC — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Summa Orthopaedics Wrist System Bone Plate — Jeil Medical Corporation · Class II
- Summa Orthopaedics Foot System Bone Plate — Jeil Medical Corporation · Class II
- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class II
- TUBULAR PLATE — Biomet Orthopedics, Inc. · Class II
- APTUS — Medartis Inc. · Class II
Cleared under the same submission
K202959 also covers:
- LapiLock — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — 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 c653f044-2a12-4c44-b621-57f2e6214ba9 35 fields · synced Jun 22, 2026