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FDA 510(k)

ARROW Anatomical Porous glenoid

K-Number: K162068 · 2017-04-10

ApplicantFournitures Hospitalieres Industrie
Decision Date2017-04-10
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARROW Anatomical Porous glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2017-04-10 under 510(k) number K162068. 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 ARROW Anatomical Porous glenoid?

ARROW Anatomical Porous glenoid is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K162068.

When did ARROW Anatomical Porous glenoid receive FDA 510(k) clearance?

ARROW Anatomical Porous glenoid received FDA 510(k) clearance on 2017-04-10, under 510(k) number K162068.

Who is the listed applicant for ARROW Anatomical Porous glenoid?

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

What is the FDA product code for ARROW Anatomical Porous glenoid?

The FDA product code for ARROW Anatomical Porous glenoid is MBF.

Other records listing Fournitures Hospitalieres Industrie 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.

K171789ARROW Reverse Porous GlenoidK163148BePOD® Foot ScrewsK163710BePOD® EZ Weil ScrewsK170040BePOD Cannulated Arthrodesis Screws

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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