The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Swanson Titanium Carpal Scaphoid Implant.
| Device ID | K864490 |
| 510k Number | K864490 |
| Device Name: | SWANSON TITANIUM CARPAL SCAPHOID IMPLANT |
| Classification | Prosthesis, Wrist, Carpal Scaphoid |
| 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 | KWO |
| CFR Regulation Number | 888.3760 [🔎] |
| 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 |
|---|---|---|
| 00840420121905 | K864490 | 000 |
| 00840420129147 | K864490 | 000 |
| 00840420129154 | K864490 | 000 |
| 00840420129161 | K864490 | 000 |
| 00840420129178 | K864490 | 000 |
| 00840420129185 | K864490 | 000 |
| 00840420132819 | K864490 | 000 |
| 00840420132826 | K864490 | 000 |
| 00840420132833 | K864490 | 000 |
| 00840420132840 | K864490 | 000 |
| 00840420121899 | K864490 | 000 |
| 00840420129130 | K864490 | 000 |