Identity
- Trade Name
- RENOVATION FDA UDI
- Generic Name
- Orthopaedic osteotome blade, single-use FDA UDI
- Device Name
- RENOVATION THIN OSTEOTOME BLADE ROUND END 20MM FDA UDI
- Model / Reference
- 71369420 FDA UDI
- Description
- RENOVATION THIN OSTEOTOME BLADE ROUND END 20MM FDA UDI
Identifiers
- Catalog Number
- 71369420 FDA UDI
- Primary DI / UDI-DI
- 03596010402950 FDA UDI
- 510(k) Number
- K123598 FDA UDI
- FDA Product Code
- JDG FDA UDI
- GMDN Term
- Orthopaedic osteotome blade, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 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 osteotome blade, single-use
Renovation by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic osteotome blade, single-use.
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- IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD. · Class I
- IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- RP Medical — Rp Medical, Inc. · Class I
- IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD. · Class I
Cleared under the same submission
K123598 also covers:
- 'SL-PLUS¿' — Smith & Nephew, Inc.
- ANTHOLOGY — Smith & Nephew, Inc.
- ANTHOLOGY — Smith & Nephew, Inc.
- Accord — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CONTOUR — 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 519de440-fd60-4290-8c42-df25959199ff 36 fields · synced Jun 8, 2026