The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Bone Graft Syringe, Model 8600-00x0.
| Device ID | K023088 |
| 510k Number | K023088 |
| Device Name: | BONE GRAFT SYRINGE, MODEL 8600-00X0 |
| Classification | Syringe, Piston |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Roger D Brown |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-09-17 |
| Decision Date | 2002-10-02 |
| Summary: | summary |