The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive 2.3mm Roc Xs Suture Bone Fastener.
| Device ID | K972438 |
| 510k Number | K972438 |
| Device Name: | INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Contact | Stephen Page |
| Correspondent | Stephen Page INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-30 |
| Decision Date | 1997-09-26 |
| Summary: | summary |