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FDA 510(k)

K-CAP-I, STERILE

K-Number: K912762 · 1991-07-18

ApplicantWestcon Orthopedics, Inc.
Decision Date1991-07-18
Product CodeLYT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K-CAP-I, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Westcon Orthopedics, Inc.. It received FDA 510(k) clearance on 1991-07-18 under 510(k) number K912762. The device is classified under product code LYT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-CAP-I, STERILE?

K-CAP-I, STERILE is a medical device that received FDA 510(k) clearance on 1991-07-18. The listed applicant is Westcon Orthopedics, Inc.. The 510(k) number is K912762.

When did K-CAP-I, STERILE receive FDA 510(k) clearance?

K-CAP-I, STERILE received FDA 510(k) clearance on 1991-07-18, under 510(k) number K912762.

Who is the listed applicant for K-CAP-I, STERILE?

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

What is the FDA product code for K-CAP-I, STERILE?

The FDA product code for K-CAP-I, STERILE is LYT.

Related Clinical Trials

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.

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Other records listing Westcon Orthopedics, 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.

K914812K-CAP-E, STERILEK902053K-CAP-I ORTHOPEDIC FIXATION WIRE CAPK901525K-CAPE ORTHOPEDIC WIRES AND PINS

Related Devices (Code: LYT)

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.

K040363CERAMIC TIPPED SKULL PINThe Jerome Group, Inc.K983685BONE BANDChapel and Assoc.K980594OSTEONICS FX-CABLELOK GRIP COMPONENTSOsteonics Corp.K914812K-CAP-E, STERILEWestcon Orthopedics, Inc.K902053K-CAP-I ORTHOPEDIC FIXATION WIRE CAPWestcon Orthopedics, Inc.K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSMicro-Aire Surgical Instruments, 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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