The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Wmt Composite Dbm.
| Device ID | K083270 |
| 510k Number | K083270 |
| Device Name: | WMT COMPOSITE DBM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Ryan M Belaney |
| Correspondent | Ryan M Belaney 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 | 2008-11-06 |
| Decision Date | 2009-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420143167 | K083270 | 000 |
| 00840420143150 | K083270 | 000 |
| 00840420143143 | K083270 | 000 |
| 00840420143136 | K083270 | 000 |