Identity
- Trade Name
- Valence Robotic Navigation System FDA UDI
- Generic Name
- Orthopaedic implantation hammering attachment FDA UDI
- Device Name
- Slap Hammer, Small FDA UDI
- Model / Reference
- 525-165 FDA UDI
- Description
- Slap Hammer, Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376585659 FDA UDI
- 510(k) Number
- K232413 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Orthopaedic implantation hammering attachment FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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 hammering attachment
Valence Robotic Navigation System by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232413 also covers:
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, INC.
- Valence Robotic Navigation System — ALPHATEC SPINE, 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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 14a8b1c0-2caa-46b8-b20c-4ff19e912516 35 fields · synced Jun 8, 2026