The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Modular Radial Head.
| Device ID | K991915 |
| 510k Number | K991915 |
| Device Name: | MODULAR RADIAL HEAD |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Lynne Witkowski |
| Correspondent | Lynne Witkowski WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-07 |
| Decision Date | 1999-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420186775 | K991915 | 000 |
| 00840420126184 | K991915 | 000 |
| 00840420126191 | K991915 | 000 |
| 00840420126207 | K991915 | 000 |
| 00840420126214 | K991915 | 000 |
| 00840420126238 | K991915 | 000 |
| 00840420126245 | K991915 | 000 |
| 00840420126252 | K991915 | 000 |
| 00840420126269 | K991915 | 000 |
| 00840420126177 | K991915 | 000 |
| 00840420126153 | K991915 | 000 |
| 00840420126061 | K991915 | 000 |
| 00840420126078 | K991915 | 000 |
| 00840420126085 | K991915 | 000 |
| 00840420126092 | K991915 | 000 |
| 00840420126115 | K991915 | 000 |
| 00840420126122 | K991915 | 000 |
| 00840420126139 | K991915 | 000 |
| 00840420126146 | K991915 | 000 |
| 00840420126276 | K991915 | 000 |
| 00840420126351 | K991915 | 000 |
| 00840420185808 | K991915 | 000 |
| 00840420185815 | K991915 | 000 |
| 00840420185822 | K991915 | 000 |
| 00840420185839 | K991915 | 000 |
| 00840420185914 | K991915 | 000 |
| 00840420186744 | K991915 | 000 |
| 00840420186751 | K991915 | 000 |
| 00840420186768 | K991915 | 000 |
| 00840420185792 | K991915 | 000 |
| 00840420185778 | K991915 | 000 |
| 00840420126368 | K991915 | 000 |
| 00840420126375 | K991915 | 000 |
| 00840420126382 | K991915 | 000 |
| 00840420126399 | K991915 | 000 |
| 00840420185716 | K991915 | 000 |
| 00840420185723 | K991915 | 000 |
| 00840420185730 | K991915 | 000 |
| 00840420185761 | K991915 | 000 |
| 00840420126054 | K991915 | 000 |