The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Compression Staple And Simple Staple.
| Device ID | K043059 |
| 510k Number | K043059 |
| Device Name: | COMPRESSION STAPLE AND SIMPLE STAPLE |
| Classification | Staple, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Katie Logerot |
| Correspondent | Katie Logerot WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-05 |
| Decision Date | 2005-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420108609 | K043059 | 000 |
| 00840420108517 | K043059 | 000 |
| 00840420108524 | K043059 | 000 |
| 00840420108531 | K043059 | 000 |
| 00840420108548 | K043059 | 000 |
| 00840420108555 | K043059 | 000 |
| 00840420108562 | K043059 | 000 |
| 00840420108579 | K043059 | 000 |
| 00840420108586 | K043059 | 000 |
| 00840420108593 | K043059 | 000 |
| 00840420108500 | K043059 | 000 |