Identity
- Trade Name
- PERI-LOC FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- PERI-LOC TGR 4.5MM DRILL TIP PROVISIONAL FIXATION PIN 80MM FDA UDI
- Model / Reference
- 71175702 FDA UDI
- Description
- PERI-LOC TGR 4.5MM DRILL TIP PROVISIONAL FIXATION PIN 80MM FDA UDI
Identifiers
- Catalog Number
- 71175702 FDA UDI
- Primary DI / UDI-DI
- 03596010611611 FDA UDI
- 510(k) Number
- K123055 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use 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
Yes
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
No
FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
The PERI-LOC TGR 4.5MM DRILL TIP and PROVISIONAL FIXATION PIN are two innovative orthopaedic intraoperative positioning pins designed to assist surgeons in safely implanting implants during orthopaedic procedures.
Similar devices
Also classified as Orthopaedic intraoperative positioning pin, single-use.
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Cleared under the same submission
K123055 also covers:
- BIRMINGHAM HIP RESURFACING(BHR) — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Jet-X — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LEGION — Smith & Nephew, Inc.
- LEGION — 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 ba6e09c3-59a8-40d5-bbe4-43d864f0fdea 36 fields · synced Jul 25, 2026