Chin Distractor

FDA 510(k) K973484 · Howmedica, Inc.

Substantially Equivalent

510(k) numberK973484

Submission

Device name
Chin Distractor
Applicant
Howmedica, Inc.
Rutherford, NJ, US
Received
September 15, 1997
Decision date
December 2, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JEY – Plate, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4760
Specialty
Dental
Implant
Yes

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Questions and answers

When was Chin Distractor cleared by the FDA?

Chin Distractor (K973484) received a 510(k) decision of Substantially Equivalent on December 2, 1997, 78 days after the submission was received.

What is the product code of K973484?

The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.