The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Swanson Titanium Trapezium Implant.
| Device ID | K864489 |
| 510k Number | K864489 |
| Device Name: | SWANSON TITANIUM TRAPEZIUM IMPLANT |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Anthony J Lentz |
| Correspondent | Anthony J Lentz DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-13 |
| Decision Date | 1987-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420121660 | K864489 | 000 |
| 00840420121653 | K864489 | 000 |
| 00840420121646 | K864489 | 000 |
| 00840420121639 | K864489 | 000 |
| 00840420121622 | K864489 | 000 |
| 00840420130600 | K864489 | 000 |
| 00840420130587 | K864489 | 000 |
| 00840420130570 | K864489 | 000 |
| 00840420130563 | K864489 | 000 |