Identity
- Trade Name
- ST.A.R. 90 F4 FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use, sterile FDA UDI
- Device Name
- Cortical bone screw with hydroxyapatite coating ø6mm L200mm-Thread L60mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609). Bone screw tip not coated. FDA UDI
- Model / Reference
- HA cortical bone screw ø6mm L200-60mm FDA UDI
- Description
- Cortical bone screw with hydroxyapatite coating ø6mm L200mm-Thread L60mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609). Bone screw tip not coated. FDA UDI
Identifiers
- Catalog Number
- ST256200HA FDA UDI
- Primary DI / UDI-DI
- 08032909624867 FDA UDI
- 510(k) Number
- K150661 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 200 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDI
Category: External orthopaedic fixation system, single-use, sterile
St.a.r. 90 F4 by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use, sterile.
- FastFrame™ — Zimmer, Inc. · Class II
- DFS HA BONE SCREWS — Biomet Orthopedics, Inc. · Class II
- Prefix Fixator — Orthofix, Inc. · Class II
- FastFrame® — Zimmer, Inc. · Class II
- Orthex Half Pin — VILEX IN TENNESSEE, INC. · Class II
- Dynex — Vilex, Inc. · Class II
- DFS HA BONE SCREWS — Biomet Orthopedics, Inc. · Class II
- Dynex — Vilex, Inc. · Class II
Cleared under the same submission
K150661 also covers:
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
- Citieffe
Sources (1)
- FDA UDI dd10f0de-a18a-4c06-abdb-04136f16f52a 38 fields · synced Jun 1, 2026