510(k) K883784

TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE by Warsaw Orthopedic, Inc. — Product Code LYQ

K883784 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE". The FDA issued a decision of SN on April 6, 1989. The device falls under product code LYQ (Accessories, Fixation, Spinal Intervertebral Body), a Class I device regulated under 21 CFR 888.4540. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 6, 1989
Date Received
September 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Fixation, Spinal Intervertebral Body
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type