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510(k) K872858

Device
WILLIAMS VERTEBRAL SPREADER
Applicant
ACE MEDICAL CO.
510(k) number
K872858
Product code
HXP  
Decision
Substantially Equivalent (SESE)
Decision date
1987-10-15
Date received
1987-07-21
Regulation
888.4540
Classification name
Instrument, Bending Or Contouring
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID W SCHLERF
Address
David W. Schlerf 921 Calle Verde Martinez CA US 94553 94553

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K800730RETROGRADE KNIFEStainless Mfg., Inc.1980-04-08
K800731MENISCAL SAWStainless Mfg., Inc.1980-04-08
K800732MENISCOTOMEStainless Mfg., Inc.1980-04-08
K800733DOUBLE-EDGE CURETTEStainless Mfg., Inc.1980-04-08

Legacy Summary#

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FDA Review#

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