Identity
- Trade Name
- ATEC Posterior Navigation Disc Prep Instruments FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- POST NAV ROTATING SHAVER, 9MM FDA UDI
- Model / Reference
- 244-17-000-09-N FDA UDI
- Description
- POST NAV ROTATING SHAVER, 9MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376529097 FDA UDI
- 510(k) Number
- K232345 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Orthopaedic chisel 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
Dimensions & Sizes
- Size
- Width — 9 Millimeter FDA UDI
Category: Orthopaedic chisel
ATEC Posterior Navigation Disc Prep Instruments by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic chisel.
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Cleared under the same submission
K232345 also covers:
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.
- ATEC Posterior Navigation Disc Prep Instruments — 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 b6c850c1-e343-43a3-9c4f-e2f9c9c5aa37 36 fields · synced Jun 8, 2026