The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for 5th Metatarsal Fracture Screw.
| Device ID | K053136 |
| 510k Number | K053136 |
| Device Name: | 5TH METATARSAL FRACTURE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Wesley L Reed |
| Correspondent | Wesley L Reed WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-09 |
| Decision Date | 2006-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420135001 | K053136 | 000 |
| 00840420134998 | K053136 | 000 |
| 00840420134981 | K053136 | 000 |
| 00840420134974 | K053136 | 000 |