510(k) K884263

ROGOZINSKI SPINAL SYSTEM by Richards Medical Co., Inc. — Product Code KWP

K884263 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "ROGOZINSKI SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on December 29, 1988. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1988
Date Received
October 11, 1988
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