Identity
- Trade Name
- LARGE CANNULATED SCREWS FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- DRILL SLEEVE 5.2MM INNER DIAMETER FDA UDI
- Model / Reference
- 71119102 FDA UDI
- Description
- DRILL SLEEVE 5.2MM INNER DIAMETER FDA UDI
Identifiers
- Catalog Number
- 71119102 FDA UDI
- Primary DI / UDI-DI
- 03596010174215 FDA UDI
- 510(k) Number
- K123055 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, 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: Orthopaedic implantation sleeve, reusable
Large Cannulated Screws by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implantation sleeve, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- gSource — GSOURCE, LLC. · Class I
- FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
- RIGID SUPRA ENTRY SLEEVE 13MM — Zimmer, Inc. · Class I
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class I
- Salvo® Spine System — Spine Wave, Inc. · Class I
- DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I
- SOFT TISSUE PROTECTOR HUDSON QUICK CONNECT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
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.
- Cannulated Screws — Smith & Nephew, Inc.
- Jet-X — 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 64f68d45-9720-4f73-8638-3a455d1b221e 36 fields · synced Jun 8, 2026