510(k) K932041
K932041 is an FDA 510(k) premarket notification submitted by Orthopaedic Biosystems for the device "XANCHOR SUTURE ATTACHMENT DEVICE". The FDA issued a decision of SN on August 12, 1994. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthopaedic Biosystems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- August 12, 1994
- Date Received
- April 27, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type