FDA.report

510(k) K990197

Device
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
Applicant
EXACTECH, INC.
510(k) number
K990197
Product code
MEH  
Decision
Substantially Equivalent (SESE)
Decision date
1999-02-04
Date received
1999-01-20
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GARY J MILLER
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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