510(k) K872858

WILLIAMS VERTEBRAL SPREADER by Ace Medical Co. — Product Code HXP

K872858 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "WILLIAMS VERTEBRAL SPREADER". The FDA issued a decision of Substantially Equivalent on October 15, 1987. The device falls under product code HXP (Instrument, Bending Or Contouring), a Class I device regulated under 21 CFR 888.4540. Ace Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1987
Date Received
July 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Bending Or Contouring
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type