Identity
- Trade Name
- ORTHROS FDA UDI
- Generic Name
- Spinal bone screw head/rod adaptor FDA UDI
- Device Name
- Polyaxial Screw Head Reduction FDA UDI
- Model / Reference
- CP-002-03 FDA UDI
- Description
- Polyaxial Screw Head Reduction FDA UDI
Identifiers
- Primary DI / UDI-DI
- B030CP002030 FDA UDI
- 510(k) Number
- K133366 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDIKWQ FDA UDI
- GMDN Term
- Spinal bone screw head/rod adaptor 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
Yes
FDA UDI
Implantable
Yes
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: Spinal bone screw head/rod adaptor
Orthros by Camber Spine Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw head/rod adaptor.
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- TAURUS — CTL Medical Corporation · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- DIPLOMAT — SIGNUS Medizintechnik GmbH · Class II
- Vertefix — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
Cleared under the same submission
K133366 also covers:
- MIS Polyaxial Pedicle Screw — CAMBER SPINE TECHNOLOGIES
- MIS Polyaxial Pedicle Screw — CAMBER SPINE TECHNOLOGIES
- MIS Polyaxial Pedicle Screw — CAMBER SPINE TECHNOLOGIES
- MIS Polyaxial Pedicle Screw — CAMBER SPINE TECHNOLOGIES
- MIS Polyaxial Pedicle Screw — CAMBER SPINE TECHNOLOGIES
- MIS Polyaxial Pedicle Screw — CAMBER SPINE TECHNOLOGIES
- ORTHROS — CAMBER SPINE TECHNOLOGIES
- ORTHROS — CAMBER SPINE TECHNOLOGIES
- ORTHROS Quarter Turn — CAMBER SPINE TECHNOLOGIES
- Orthros — CAMBER SPINE TECHNOLOGIES
- Orthros — CAMBER SPINE TECHNOLOGIES
- Orthros — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Camber Spine Technologies
Sources (1)
- FDA UDI 21223c04-35d3-4457-87e0-bbfd7f17fb85 35 fields · synced May 30, 2026