Identity
- Trade Name
- ALTIVO Anterior Cervical Fixation System FDA UDI
- Generic Name
- Surgical instrument interim-placement holder, reusable FDA UDI
- Device Name
- 2-2 Assembly Block Base, FORTICO System FDA UDI
- Model / Reference
- FCP-502-002 FDA UDI
- Description
- 2-2 Assembly Block Base, FORTICO System FDA UDI
Identifiers
- Primary DI / UDI-DI
- B030FCP5020020 FDA UDI
- 510(k) Number
- K191584 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Surgical instrument interim-placement holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument interim-placement holder, reusable
ALTIVO Anterior Cervical Fixation System by Camber Spine Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument interim-placement holder, reusable.
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- Reicodent — devemed GmbH · Class I
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Cleared under the same submission
K191584 also covers:
- ALTIVO Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
- ALTIVO™ Anterior Cervical Fixation System — CAMBER SPINE TECHNOLOGIES
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
- Camber Spine Technologies
Sources (1)
- FDA UDI ec5da33e-3be9-4f4c-b0c2-8cd7ff184f04 35 fields · synced May 30, 2026