Identity
- Trade Name
- 2.8 mm Inion CPS® FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- 2.8 x 10 mm screw FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 2.8 x 10 mm screw FDA UDI
Identifiers
- Catalog Number
- SCR-1212 FDA UDI
- Primary DI / UDI-DI
- M224SCR12129 FDA UDI
- 510(k) Number
- K020266 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Bioabsorbable orthopaedic bone screw 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bioabsorbable orthopaedic bone screw
2.8 mm Inion CPS® by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioabsorbable orthopaedic bone screw.
- MILAGRO — DePuy Mitek, Inc. · Class II
- ActivaScrew™ — Bioretec Oy · Class II
- MILAGRO — Medos International Sàrl · Class II
- Arthrex® — Arthrex, Inc. · Class II
- MILAGRO — Medos International Sàrl · Class II
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc. · Class II
- Gentle Threads — Biomet Orthopedics, Inc. · Class II
- ActivaScrew™ — Bioretec Oy · Class II
Cleared under the same submission
K020266 also covers:
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
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
- Inion , Ltd.
Sources (1)
- FDA UDI 6d14f1e0-1358-49fa-b335-34c228a19f08 36 fields · synced May 31, 2026