Identity
- Trade Name
- PERI-LOC ANKLE FUSION PLATING SYSTEM FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- PERI-LOC 3.5MM ANKLE FUSION POSTERIOR LEFT 80MM TEMPLATE FDA UDI
- Model / Reference
- 71111035 FDA UDI
- Description
- PERI-LOC 3.5MM ANKLE FUSION POSTERIOR LEFT 80MM TEMPLATE FDA UDI
Identifiers
- Catalog Number
- 71111035 FDA UDI
- Primary DI / UDI-DI
- 00885556208793 FDA UDI
- 510(k) Number
- K110670 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical implant template, reusable 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant template, reusable
Peri-Loc Ankle Fusion Plating System by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, reusable.
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- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
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- APTUS — Medartis Inc. · Class II
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Cleared under the same submission
K110670 also covers:
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
- PERI-LOC ANKLE FUSION PLATING SYSTEM — Smith & Nephew, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI f3dce700-2875-4a77-a39b-f7d6ce768179 36 fields · synced Jun 8, 2026