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FDA 510(k)

COFIELD SHOULDER SYSTEM

K-Number: K855183 · 1986-03-26

ApplicantRichards Medical Co., Inc.
Decision Date1986-03-26
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COFIELD SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1986-03-26 under 510(k) number K855183. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COFIELD SHOULDER SYSTEM?

COFIELD SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-26. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K855183.

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

COFIELD SHOULDER SYSTEM received FDA 510(k) clearance on 1986-03-26, under 510(k) number K855183.

Who is the listed applicant for COFIELD SHOULDER SYSTEM?

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

What is the FDA product code for COFIELD SHOULDER SYSTEM?

The FDA product code for COFIELD SHOULDER SYSTEM is KWS.

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Other records listing Richards Medical Co., Inc. as applicant

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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

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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