510(k) K781449

HARRINGTON SPINAL ELEVATOR by Orthopedic Equipment Co., Inc. — Product Code GEG

K781449 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "HARRINGTON SPINAL ELEVATOR". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code GEG (Elevator, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1978
Date Received
August 23, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type