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FDA 510(k)

POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS

K-Number: K844415 · 1985-01-23

ApplicantDepuy, Inc.
Decision Date1985-01-23
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1985-01-23 under 510(k) number K844415. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS?

POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Depuy, Inc.. The 510(k) number is K844415.

When did POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS receive FDA 510(k) clearance?

POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS received FDA 510(k) clearance on 1985-01-23, under 510(k) number K844415.

Who is the listed applicant for POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS?

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

What is the FDA product code for POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS?

The FDA product code for POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS is MBF.

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Other records listing Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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Related Devices (Code: MBF)

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.

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.

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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