The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Osteo-cable Sleeve.
Device ID | K024022 |
510k Number | K024022 |
Device Name: | OSTEO-CABLE SLEEVE |
Classification | Applier, Cerclage |
Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
Contact | Kacy Arnold |
Correspondent | Kacy Arnold BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
Product Code | HXN |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-05 |
Decision Date | 2003-01-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304360556 | K024022 | 000 |
00880304002708 | K024022 | 000 |