The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Endofuse Intra-osseous Fusion System.
| Device ID | K102324 |
| 510k Number | K102324 |
| Device Name: | ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Sarah Holtgrewe |
| Correspondent | Sarah Holtgrewe 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 | 2010-08-17 |
| Decision Date | 2011-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420143174 | K102324 | 000 |
| 00840420141071 | K102324 | 000 |
| 00840420141064 | K102324 | 000 |
| 00840420141057 | K102324 | 000 |
| 00840420141040 | K102324 | 000 |
| 00840420141033 | K102324 | 000 |
| 00840420141026 | K102324 | 000 |
| 00840420141019 | K102324 | 000 |
| 00840420141002 | K102324 | 000 |
| 00840420140999 | K102324 | 000 |
| 00840420140982 | K102324 | 000 |
| 00840420140975 | K102324 | 000 |
| 00840420140968 | K102324 | 000 |
| 00840420140951 | K102324 | 000 |
| 00840420140944 | K102324 | 000 |
| 00840420140937 | K102324 | 000 |
| 00840420140920 | K102324 | 000 |
| 00840420141088 | K102324 | 000 |
| 00840420141095 | K102324 | 000 |
| 00840420142733 | K102324 | 000 |
| 00840420142726 | K102324 | 000 |
| 00840420142719 | K102324 | 000 |
| 00840420141231 | K102324 | 000 |
| 00840420141217 | K102324 | 000 |
| 00840420141200 | K102324 | 000 |
| 00840420141194 | K102324 | 000 |
| 00840420141187 | K102324 | 000 |
| 00840420141170 | K102324 | 000 |
| 00840420141163 | K102324 | 000 |
| 00840420141156 | K102324 | 000 |
| 00840420141149 | K102324 | 000 |
| 00840420141132 | K102324 | 000 |
| 00840420141125 | K102324 | 000 |
| 00840420141118 | K102324 | 000 |
| 00840420141101 | K102324 | 000 |
| 00840420140913 | K102324 | 000 |