Identity
- Trade Name
- CREO FDA UDI
- Generic Name
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- CREO 4.75 Threaded 10.5 x 35mm Polyaxial Screw, CoCr Head, Ti Shank FDA UDI
- Model / Reference
- 5067.1137 FDA UDI
- Description
- CREO 4.75 Threaded 10.5 x 35mm Polyaxial Screw, CoCr Head, Ti Shank FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889095261158 FDA UDI
- 510(k) Number
- K143633 FDA UDI
- FDA Product Code
- KWQ FDA UDIOSH FDA UDIMNI FDA UDIMNH FDA UDIKWP FDA UDINKB FDA UDI
- GMDN Term
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3070 FDA UDI888.3050 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
No
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
- Length — 35 Millimeter FDA UDIOuter Diameter — 10.5 Millimeter FDA UDI
Category: Trans-facet-screw internal spinal fixation system, sterile
Creo by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trans-facet-screw internal spinal fixation system, sterile.
- FacetFuse® — SPINEFRONTIER, INC. · U
- CONCERO FACET SCREW SYSTEM — BIOMET SPINE LLC · U
- FacetFuse® — SPINEFRONTIER, INC. · U
- JAZZ System — Implanet · Class II
- Concero™ Facet Screw System — BIOMET SPINE LLC · U
- CREO — GLOBUS MEDICAL, INC. · Class II
- CREO — GLOBUS MEDICAL, INC. · Class II
- SI-LOK — GLOBUS MEDICAL, INC. · Class II
Cleared under the same submission
K143633 also covers:
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, INC.
- CREO — GLOBUS MEDICAL, 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
- Globus Medical, Inc.
Sources (1)
- FDA UDI 802ba571-b267-4d8a-b4fd-8bda1ed2a875 36 fields · synced May 30, 2026