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510(k) K883784

Device
TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
Applicant
WARSAW ORTHOPEDIC, INC.
510(k) number
K883784
Product code
LYQ  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1989-04-06
Date received
1988-09-06
Regulation
888.4540
Classification name
Accessories, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES RITTER
Address
P.O. Box 1157 Warsaw IN US 46580 46580

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893415TRANS-ORAL DEPTH GAUGERuggles Corp.1989-06-07
K882871CASF DRILL GUIDE DG 170Terray Manufacturing, Inc.1988-09-23

Legacy Summary#

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FDA Review#

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