The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Osteoset Dbm Pellets.
| Device ID | K053642 |
| 510k Number | K053642 |
| Device Name: | OSTEOSET DBM PELLETS |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Theresa Leister |
| Correspondent | Theresa Leister WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-30 |
| Decision Date | 2006-01-26 |
| Summary: | summary |