The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Minvasive Suture Bone Fastener.
| Device ID | K924034 |
| 510k Number | K924034 |
| Device Name: | MINVASIVE SUTURE BONE FASTENER |
| Classification | Staple, Fixation, Bone |
| Applicant | INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton, MA 01748 |
| Contact | Eric Bannon |
| Correspondent | Eric Bannon INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton, MA 01748 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-11 |
| Decision Date | 1993-08-24 |