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FDA 510(k)

PROMOS MODULAR SHOULDER SYSTEM

K-Number: K063578 · 2007-03-02

ApplicantPlus Orthopedics AG
Decision Date2007-03-02
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROMOS MODULAR SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics AG. It received FDA 510(k) clearance on 2007-03-02 under 510(k) number K063578. 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 MODULAR SHOULDER SYSTEM?

PROMOS MODULAR SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-02. The listed applicant is Plus Orthopedics AG. The 510(k) number is K063578.

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

PROMOS MODULAR SHOULDER SYSTEM received FDA 510(k) clearance on 2007-03-02, under 510(k) number K063578.

Who is the listed applicant for PROMOS MODULAR SHOULDER SYSTEM?

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

What is the FDA product code for PROMOS MODULAR SHOULDER SYSTEM?

The FDA product code for PROMOS MODULAR SHOULDER SYSTEM is HSD.

Related Clinical Trials

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Other records listing Plus Orthopedics AG as applicant

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Related Devices (Code: HSD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.

Official Source

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

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