510(k) K024022
K024022 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "OSTEO-CABLE SLEEVE". The FDA issued a decision of Substantially Equivalent on January 23, 2003. The device falls under product code HXN (Applier, Cerclage), a Class I device regulated under 21 CFR 888.4540. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2003
- Date Received
- December 5, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Cerclage
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type