The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Lactosorb Mini Interference Screw.
Device ID | K021254 |
510k Number | K021254 |
Device Name: | LACTOSORB MINI INTERFERENCE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | BIOMET ORTHOPEDICS, INC. 56 EAS BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
Contact | Sara B Shultz |
Correspondent | Sara B Shultz BIOMET ORTHOPEDICS, INC. 56 EAS BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-19 |
Decision Date | 2002-07-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304423688 | K021254 | 000 |