The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Soribie Resurfacing Total Elbow System (proposed Name).
| Device ID | K960087 |
| 510k Number | K960087 |
| Device Name: | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) |
| 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 | 1996-01-11 |
| Decision Date | 1996-09-20 |
| Summary: | summary |