FDA.reportPublic FDA data

SURGTECH, INC.

Matched from indexed company URL: SurgTech Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30111704103011170410SURGTECH, INC.1N2026-01-0124600 Center Ridge Road, Suite 195 Westlake OH US 44145

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1748231203562276K191192SurgTech GENOLL Total Knee SystemJWH2019-08-01
1748231038928594K173455SurgTech Bipolar Head SystemKWY2018-06-14
1748231082106834K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemNKB2017-04-05
1748231596556637K162125MALUC™ Total Hip Arthroplasty SystemJDI2017-05-10
1748231268607304K161894SurgTech Trauma SystemHWC2017-02-21
1748231847607751K152200SurgTech Interbody SystemMAX2016-03-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH22019-08-01
KWY22018-06-14
JDI22017-05-10
NKB22017-04-05
HWC22017-02-21
MAX22016-03-25

PMN#