510(k) K880211

TSRH H/M HOOK HOLDER by Warsaw Orthopedic, Inc. — Product Code KWP

K880211 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "TSRH H/M HOOK HOLDER". The FDA issued a decision of Substantially Equivalent on March 4, 1988. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1988
Date Received
January 19, 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