510(k) K883457
K883457 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "ASST-3000 SPINAL SURGERY TABLE". The FDA issued a decision of Substantially Equivalent on August 26, 1988. The device falls under product code FWY (Table, Operating-Room, Non-Electrical), a Class I device regulated under 21 CFR 878.4950. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1988
- Date Received
- August 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Non-Electrical
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type