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FDA 510(k)

ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM

K-Number: K935593 · 1994-10-14

ApplicantBiodynamic Technologies, Inc.
Decision Date1994-10-14
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamic Technologies, Inc.. It received FDA 510(k) clearance on 1994-10-14 under 510(k) number K935593. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM?

ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM is a medical device that received FDA 510(k) clearance on 1994-10-14. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K935593.

When did ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM receive FDA 510(k) clearance?

ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM received FDA 510(k) clearance on 1994-10-14, under 510(k) number K935593.

Who is the listed applicant for ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM?

The FDA 510(k) record lists Biodynamic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM?

The FDA product code for ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM is HSD.

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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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