510(k) K951451
K951451 is an FDA 510(k) premarket notification submitted by Orthopaedic Biosystems, Ltd. for the device "PEBA ANCHOR (MULTIPLE SIZES)". The FDA issued a decision of SN on October 31, 1995. 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
- SN ()
- Decision Date
- October 31, 1995
- Date Received
- March 29, 1995
- 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