The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive 1.9mm, 2.8mm, 3.5mm, 4.5mm Roc Suture Bone Fastener.
| Device ID | K944831 |
| 510k Number | K944831 |
| Device Name: | INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | INNOVASIVE DEVICES, INC. 100-B SOUTH ST. Hopkinton, MA 01748 |
| Contact | Eric Bannon |
| Correspondent | Eric Bannon INNOVASIVE DEVICES, INC. 100-B SOUTH ST. Hopkinton, MA 01748 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1995-02-01 |