The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix Dr Putty, Ignite Scaffold, Models 860c, 86xc, 86dr, 860d, 860t.
| Device ID | K040980 |
| 510k Number | K040980 |
| Device Name: | ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T |
| 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 | 2004-04-15 |
| Decision Date | 2004-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420133540 | K040980 | 000 |
| 00840420133533 | K040980 | 000 |
| 00840420133526 | K040980 | 000 |
| 00840420133496 | K040980 | 000 |