510(k) K983881
K983881 is an FDA 510(k) premarket notification submitted by Orthopaedic Innovations, Inc. for the device "COBRA EXTERNAL FIXATOR". The FDA issued a decision of Substantially Equivalent on December 4, 1998. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthopaedic Innovations, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1998
- Date Received
- November 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type