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510(k) K833726

Device
KLEIN WIRE TIGHTENER/BIONIC WIRE
Applicant
BIONIC INSTRUMENT CORP.
510(k) number
K833726
Product code
HXS  
Decision
Substantially Equivalent (SESE)
Decision date
1983-12-22
Date received
1983-10-24
Regulation
888.4540
Classification name
Twister, Wire
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K781451FLAT WRENCHOrthopedic Equipment Co., Inc.1978-09-27

Legacy Summary#

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FDA Review#

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