Identity
- Trade Name
- Altus Spine Pedicle Screw System FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Head Positioner FDA UDI
- Model / Reference
- 905-0042 FDA UDI
- Description
- Head Positioner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210131986 FDA UDI
- 510(k) Number
- K181281 FDA UDI
- FDA Product Code
- NKB FDA UDIKWQ FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Altus Spine Pedicle Screw System by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
K181281 also covers:
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
- Altus Spine Pedicle Screw System — Altus Spine
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Altus Spine
Sources (1)
- FDA UDI 92a6583d-458d-4f8c-8c20-cdf4c194145a 35 fields · synced Jun 1, 2026