FDA.reportPublic FDA data

510(k) K894184

Device
BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM
Applicant
BIEDERMANN MOTECH GMBH
510(k) number
K894184
Product code
JDN  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1990-04-25
Date received
1989-06-16
Regulation
888.3060
Classification name
Implant, Fixation Device, Spinal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LUTZ BIEDERMANN
Address
Berta-Suttner-Strasse 23 Vs-Schwenningen DE D-78054 D-78054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JDN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954856CANNULATED FEMORAL NAILSynthes (Usa)1996-03-08
K897141SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIOStuart1990-06-21
K872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYRoseburg SA1987-12-07
K873977NEW C-D SYSTEM FOR SPINAL SURGERYSofamor Co.1987-12-07
K760649TOTAL SPINAL CORRECTIONDepuy, Inc.1976-10-05

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases