The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Allomatrix Tcp, Allomatrix W/caso4 Filled Tcp, And Allomatrix Plus Cbm.
| Device ID | K041663 |
| 510k Number | K041663 |
| Device Name: | ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Brian J Young |
| Correspondent | Brian J Young WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-18 |
| Decision Date | 2004-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420149220 | K041663 | 000 |
| 00840420134943 | K041663 | 000 |
| 00840420134707 | K041663 | 000 |