Identity
- Trade Name
- Orthros FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Model / Reference
- Ø6.5mm Polyaxial Pedicle Screw, 30mm Lg. FDA UDI
Identifiers
- Catalog Number
- CP-004-14 FDA UDI
- Primary DI / UDI-DI
- B030CP004140 FDA UDI
- 510(k) Number
- K133366 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone screw, non-bioabsorbable
The Orthros device is a non-magnetic, non-sterile spinal bone screw implantable in the spine for stabilizing spinal segments. Made of surgical steel, titanium alloy, or carbon fibre, it provides immobilization and stabilization to treat spinal instabilities or deformities.
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · 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 5548ac0f-117b-4bdd-9cde-8084af20a159 34 fields · synced Jul 7, 2026