Identity
- Trade Name
- Align FDA UDI
- Generic Name
- Elbow radius prosthesis FDA UDI
- Model / Reference
- ALIGN Radial Stem, 10mm x 0mm FDA UDI
Identifiers
- Catalog Number
- ALN-RST-1000 FDA UDI
- Primary DI / UDI-DI
- 00841506100210 FDA UDI
- 510(k) Number
- K092721 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
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDI
Category: Elbow radius prosthesis
Align by Skeletal Dynamics L.l.c. — 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
- 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
K092721 also covers:
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
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
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI b7647017-c16e-44c9-9d1e-1ab0b96ac891 36 fields · synced May 31, 2026