FDA 510(k) Premarket Notification K972928: KERBOULL CROSS

Submission Details & Decision

Normalized public record details for 510(k) notification K972928.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K972928

Applicant / Sponsor

Howmedica, Inc.

Device Name

KERBOULL CROSS

Product Code

JDI

Decision Date

1997-11-03

Decision / Status

Substantially Equivalent for Some Indications (SN)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

1997-08-08

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