The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Allomatrix Custom.
| Device ID | K053319 |
| 510k Number | K053319 |
| Device Name: | ALLOMATRIX CUSTOM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Brian Young |
| Correspondent | Brian 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 | 2005-11-30 |
| Decision Date | 2006-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420133519 | K053319 | 000 |
| 00840420133502 | K053319 | 000 |