The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Devices Rotator Cuff Fastener.
Device ID | K951565 |
510k Number | K951565 |
Device Name: | INNOVASIVE DEVICES ROTATOR CUFF FASTENER |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton, MA 01748 |
Contact | Eriv Bannon |
Correspondent | Eriv Bannon INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton, MA 01748 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-04 |
Decision Date | 1995-09-08 |