The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Sorbie Total Elbow System.
| Device ID | K955099 |
| 510k Number | K955099 |
| Device Name: | SORBIE TOTAL ELBOW SYSTEM |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| 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 | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-07 |
| Decision Date | 1996-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420129321 | K955099 | 000 |
| 00840420129314 | K955099 | 000 |
| 00840420129307 | K955099 | 000 |
| 00840420129291 | K955099 | 000 |
| 00840420129284 | K955099 | 000 |
| 00840420129277 | K955099 | 000 |
| 00840420129260 | K955099 | 000 |
| 00840420129253 | K955099 | 000 |
| 00840420129246 | K955099 | 000 |