FDA 510(k) Premarket Notification K940328: PRIME CEMENTED HIP SYSTEM

Submission Details & Decision

Normalized public record details for 510(k) notification K940328.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K940328

Applicant / Sponsor

Orthopaedic Innovations, Inc.

Device Name

PRIME CEMENTED HIP SYSTEM

Product Code

JDI

Decision Date

1995-04-07

Decision / Status

Substantially Equivalent for Some Indications (SN)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

1994-01-24

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