510(k) K972326
K972326 is an FDA 510(k) premarket notification submitted by Orthopaedic Biosystems, Ltd. for the device "PEBA ANCHOR/SUTURE COMBINATION". The FDA issued a decision of Substantially Equivalent on February 6, 1998. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Orthopaedic Biosystems, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1998
- Date Received
- June 23, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type