The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Swanson Titanium Great Toe Implant.
| Device ID | K864492 |
| 510k Number | K864492 |
| Device Name: | SWANSON TITANIUM GREAT TOE IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| 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 | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| 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 |
|---|---|---|
| 00840420121752 | K864492 | 000 |
| 00840420125651 | K864492 | 000 |
| 00840420125668 | K864492 | 000 |
| 00840420125675 | K864492 | 000 |
| 00840420125682 | K864492 | 000 |
| 00840420125699 | K864492 | 000 |
| 00840420198693 | K864492 | 000 |
| 00840420198709 | K864492 | 000 |
| 00840420198716 | K864492 | 000 |
| 00840420198723 | K864492 | 000 |
| 00840420198730 | K864492 | 000 |
| 00840420121714 | K864492 | 000 |
| 00840420121721 | K864492 | 000 |
| 00840420121738 | K864492 | 000 |
| 00840420121745 | K864492 | 000 |
| 00840420125644 | K864492 | 000 |