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FDA 510(k)

PROMOS SHOULDER

K-Number: K032126 · 2004-01-08

ApplicantPlus Orthopedics
Decision Date2004-01-08
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROMOS SHOULDER is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2004-01-08 under 510(k) number K032126. 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 PROMOS SHOULDER?

PROMOS SHOULDER is a medical device that received FDA 510(k) clearance on 2004-01-08. The listed applicant is Plus Orthopedics. The 510(k) number is K032126.

When did PROMOS SHOULDER receive FDA 510(k) clearance?

PROMOS SHOULDER received FDA 510(k) clearance on 2004-01-08, under 510(k) number K032126.

Who is the listed applicant for PROMOS SHOULDER?

The FDA 510(k) record lists Plus Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROMOS SHOULDER?

The FDA product code for PROMOS SHOULDER is HSD.

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Other records listing Plus Orthopedics 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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