510(k) K953961
K953961 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code FWW (Table, Operating-Room, Pneumatic), a Class I device regulated under 21 CFR 878.4960. Osteonics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1995
- Date Received
- August 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Pneumatic
- Device Class
- Class I
- Regulation Number
- 878.4960
- Review Panel
- SU
- Submission Type