FDA.reportPublic FDA data

510(k) K973031

Device
STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE
Applicant
R. THOMAS GROTZ, M.D., INC.
510(k) number
K973031
Product code
MRI  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-03
Date received
1997-08-14
Regulation
890.3490
Classification name
Orthosis, Truncal/orthosis, Limb
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
R. THOMAS GROTZ
Address
530 Bush St., 10th Floor San Francisco CA US 94108 94108

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923880ORLAU SWIVEL WALKERMopac, Ltd.1996-09-30

Legacy Summary#

summary

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