FDA.report

510(k) K951114

Device
SYSTEM 12 P1 26MM ACETABULAR INSERT
Applicant
HOWMEDICA CORP.
510(k) number
K951114
Product code
LPH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-16
Date received
1995-03-10
Regulation
888.3358
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MARY C SPICER
Address
359 Veterans Blvd. Rutherford NJ US 07070 07070

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
57613327545222System 12Howmedica Osteonics Corp.2020-11-24

Legacy Summary

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FDA Review

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