FDA 510(k) Premarket Notification K854107: DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

Submission Details & Decision

Normalized public record details for 510(k) notification K854107.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K854107

Applicant / Sponsor

Kirschner Medical Corp.

Device Name

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

Product Code

JDL

Decision Date

1986-03-10

Decision / Status

Substantially Equivalent for Some Indications (SN)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

1985-10-08

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