510(k) K982996
K982996 is an FDA 510(k) premarket notification submitted by Orthopaedic Biosystems, Ltd. for the device "POLYMER OBL SB ANCHOR / SUTURE COMBINATION". The FDA issued a decision of Substantially Equivalent on March 4, 1999. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthopaedic Biosystems, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1999
- Date Received
- August 27, 1998
- 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