Identity
- Trade Name
- Avenger FDA UDI
- Generic Name
- Elbow radius prosthesis FDA UDI
- Device Name
- Avenger Radial Head Stem Implant, Size Ø7.5 x 25 mm, +4mm FDA UDI
- Model / Reference
- M70 SC375 FDA UDI
- Description
- Avenger Radial Head Stem Implant, Size Ø7.5 x 25 mm, +4mm FDA UDI
Identifiers
- Catalog Number
- M70 SC375 FDA UDI
- Primary DI / UDI-DI
- 00810021866376 FDA UDI
- 510(k) Number
- K212872 FDA UDI
- FDA Product Code
- KWI FDA UDI
- GMDN Term
- Elbow radius prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3170 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
No
FDA UDI
MR Conditional FDA UDI
Category: Elbow radius prosthesis
Avenger by In2Bones, USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Elbow radius prosthesis.
- LATITUDE EV™ — TORNIER, INC. · Class II
- RHEAD — Stryker Corp. · Class II
- Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
- Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
- Align — SKELETAL DYNAMICS L.L.C. · Class II
- Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
- LATITUDE EV™ — TORNIER, INC. · Class II
- L2L® — Zimmer, Inc. · Class II
Cleared under the same submission
K212872 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
- In2Bones, USA
Sources (1)
- FDA UDI 02bcba92-4de5-467b-b68a-d7d117829aef 36 fields · synced Jun 1, 2026