The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Allomatrix Model# 86.
| Device ID | K020895 |
| 510k Number | K020895 |
| Device Name: | ALLOMATRIX MODEL# 86 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Roger D Brown |
| Correspondent | Roger D Brown 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 | 2002-03-19 |
| Decision Date | 2004-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420133588 | K020895 | 000 |
| 00840420133571 | K020895 | 000 |
| 00840420133564 | K020895 | 000 |
| 00840420133557 | K020895 | 000 |