The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Arthroscopic Roc Suture Bone Fastener.
Device ID | K941273 |
510k Number | K941273 |
Device Name: | INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER |
Classification | Arthroscope |
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 | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-16 |
Decision Date | 1994-09-16 |