510(k) K935113

J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE by J.B.S., S.A. — Product Code KWP

K935113 is an FDA 510(k) premarket notification submitted by J.B.S., S.A. for the device "J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on Oct 19, 1994. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. J.B.S., S.A. has 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 19, 1994
Date Received
Oct 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K935113. Report a data issue: hello@regdatalab.com.