FDA.reportPublic FDA data

SIGNAL MEDICAL CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18360013002477077SIGNAL MEDICAL CORP.1N2020-04-25400 PYRAMID DR. MARYSVILLE MI US 48040

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B046BIO110210Slide Block - Knee Positioner Slide Block8103647070vfowler@signalmd.com
B046BIO110220Boot Assembly - Knee Positioner Boot Assembly8103647070vfowler@signalmd.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
168942013919349K971721WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEADLZO1997-07-30
168941371469049K971718MICRO-SEAL ACETABULAR SYSTEMLPH1997-07-23
168941849321282K964150WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEADLZO1996-12-27
168941237267552K961625QUATROLOC FEMORAL COMPONENT & HEADLPH1996-09-10
168941920951748K961157WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREWHWC1996-05-17
168941006054153K951844BIOMECHANIC LOW-PROFILE CABLE SYSTEMJDQ1995-07-13
168941106225132K100370SYMMETRIC TOTAL KNEE AGUMENTSJWH2011-03-07
168942053526638K080199SYMMETRIC TOTAL KNEE SYSTEMJWH2008-07-03
168941927275065K033313QUATRO M FEMORAL COMPONENTLWJ2004-07-28
168941494961114K012800SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEMHRY2002-05-03
168941597776249

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH22011-03-07
LZO21997-07-30
LPH21997-07-23
LWJ12004-07-28
HRY12002-05-03
HWC11996-05-17
JDQ11995-07-13

PMN#

GUDID#

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