The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Suture Bone Fastener With Suture.
Device ID | K935321 |
510k Number | K935321 |
Device Name: | INNOVASIVE SUTURE BONE FASTENER WITH SUTURE |
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 | 1993-11-04 |
Decision Date | 1994-10-19 |