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510(k) K830255

Device
OSTEOTOMY BONE STAPLE
Applicant
TECHMEDICA, INC.
510(k) number
K830255
Product code
HXJ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-09
Date received
1983-01-25
Regulation
888.4540
Classification name
Staple Driver
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964953IN-TAC BONE ANCHOR SYSTEMInfluence, Inc.1997-02-13
K962372UROTAC BONE ANCHOR INSERTERInfluence, Inc.1996-08-19
K930205ELECTRIC WIRE DRIVER, MODEL 2640EMicro Surgical Instruments Corp.1993-08-02
K834515FIXATION STAPLE KIT - DLIDE HAMMERStryker Corp.1984-04-23
K830456STAPLE INSERTER-EXTRACTOR FOR ARTHROSInstrument Makar, Inc.1983-03-09

Legacy Summary#

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FDA Review#

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