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FDA 510(k)

SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS

K-Number: K111620 · 2011-08-23

ApplicantSkeletal Dynamics, LLC
Decision Date2011-08-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2011-08-23 under 510(k) number K111620. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS?

SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS is a medical device that received FDA 510(k) clearance on 2011-08-23. The listed applicant is Skeletal Dynamics, LLC. The 510(k) number is K111620.

When did SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS receive FDA 510(k) clearance?

SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS received FDA 510(k) clearance on 2011-08-23, under 510(k) number K111620.

Who is the listed applicant for SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS?

The FDA 510(k) record lists Skeletal Dynamics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS?

The FDA product code for SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS is HRS.

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Other records listing Skeletal Dynamics, LLC as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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