The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive 3.5mm Metal Roc Xs Suture Bone Fastener.
Device ID | K981193 |
510k Number | K981193 |
Device Name: | INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
Contact | Stephen M Page |
Correspondent | Stephen M Page INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-02 |
Decision Date | 1998-06-16 |
Summary: | summary |