The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Devices Meniscal Screw.
Device ID | K980681 |
510k Number | K980681 |
Device Name: | INNOVASIVE DEVICES MENISCAL SCREW |
Classification | Screw, Fixation, Bone |
Applicant | INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
Contact | Eric Bannon |
Correspondent | Eric Bannon INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-20 |
Decision Date | 1998-04-29 |
Summary: | summary |