The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Titanium Cannulated Interference Screw.
Device ID | K021030 |
510k Number | K021030 |
Device Name: | TITANIUM CANNULATED INTERFERENCE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | FUTURE MEDICAL SYSTEMS, INC. 504 MCCORMICK DR., SUITE T Glen Burnie, MD 21061 |
Contact | Patrick Janin |
Correspondent | Patrick Janin FUTURE MEDICAL SYSTEMS, INC. 504 MCCORMICK DR., SUITE T Glen Burnie, MD 21061 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-29 |
Decision Date | 2002-06-25 |
Summary: | summary |