510(k) K870126
K870126 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "FEMUR WRENCH". The FDA issued a decision of Substantially Equivalent on February 3, 1987. The device falls under product code GEG (Elevator, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1987
- Date Received
- January 12, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elevator, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type