The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Radial Head Prosthesis.
| Device ID | K992220 |
| 510k Number | K992220 |
| Device Name: | RADIAL HEAD PROSTHESIS |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Janet Johnson Green |
| Correspondent | Janet Johnson Green SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-01 |
| Decision Date | 2000-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556044926 | K992220 | 000 |
| 00885556044841 | K992220 | 000 |
| 00885556044629 | K992220 | 000 |
| 00885556044353 | K992220 | 000 |