The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Bone Fusion Plate System.
| Device ID | K042205 |
| 510k Number | K042205 |
| Device Name: | BONE FUSION PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Jeanine H Redden |
| Correspondent | Jeanine H Redden WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-16 |
| Decision Date | 2004-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420108289 | K042205 | 000 |
| 00840420108166 | K042205 | 000 |
| 00840420108159 | K042205 | 000 |
| 00840420108142 | K042205 | 000 |
| 00840420108135 | K042205 | 000 |
| 00840420108128 | K042205 | 000 |
| 00840420108111 | K042205 | 000 |
| 00840420108043 | K042205 | 000 |
| 00840420108036 | K042205 | 000 |
| 00840420108029 | K042205 | 000 |
| 00840420108173 | K042205 | 000 |
| 00840420108180 | K042205 | 000 |
| 00840420108272 | K042205 | 000 |
| 00840420108265 | K042205 | 000 |
| 00840420108258 | K042205 | 000 |
| 00840420108241 | K042205 | 000 |
| 00840420108234 | K042205 | 000 |
| 00840420108227 | K042205 | 000 |
| 00840420108210 | K042205 | 000 |
| 00840420108203 | K042205 | 000 |
| 00840420108197 | K042205 | 000 |
| 00840420108012 | K042205 | 000 |