Identity
- Trade Name
- BioPoly® Radial Head Implant FDA UDI
- Generic Name
- Elbow radius prosthesis FDA UDI
- Device Name
- BioPoly® Radial Head Implant, 23 x 6(+6)mm FDA UDI
- Model / Reference
- 160-5366 FDA UDI
- Description
- BioPoly® Radial Head Implant, 23 x 6(+6)mm FDA UDI
Identifiers
- Catalog Number
- 160-5366 FDA UDI
- Primary DI / UDI-DI
- 00850005618461 FDA UDI
- 510(k) Number
- K233592 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
Category: Elbow radius prosthesis
BioPoly® Radial Head Implant by BioPoly, LLC — 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
- Avenger — In2Bones, USA · 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
Cleared under the same submission
K233592 also covers:
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
- BioPoly® Radial Head Implant — BioPoly, LLC
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
- BioPoly, LLC
Sources (1)
- FDA UDI 7c806b5c-7dc0-43f4-bb52-5f57c319950d 36 fields · synced May 30, 2026