The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Metallic Radial Head Implants.
| Device ID | K944507 |
| 510k Number | K944507 |
| Device Name: | METALLIC RADIAL HEAD IMPLANTS |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Judy English |
| Correspondent | Judy English WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1995-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420198808 | K944507 | 000 |
| 00840420129208 | K944507 | 000 |
| 00840420129215 | K944507 | 000 |
| 00840420129222 | K944507 | 000 |
| 00840420129239 | K944507 | 000 |
| 00840420132932 | K944507 | 000 |
| 00840420132949 | K944507 | 000 |
| 00840420190079 | K944507 | 000 |
| 00840420190086 | K944507 | 000 |
| 00840420190093 | K944507 | 000 |
| 00840420198761 | K944507 | 000 |
| 00840420198778 | K944507 | 000 |
| 00840420198785 | K944507 | 000 |
| 00840420198792 | K944507 | 000 |
| 00840420129192 | K944507 | 000 |