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FDA 510(k)

LINVATEC STASYS-PES FIXATION DEVICE

K-Number: K934321 · 1995-05-10

ApplicantLinvatec Corp.
Decision Date1995-05-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINVATEC STASYS-PES FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K934321. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINVATEC STASYS-PES FIXATION DEVICE?

LINVATEC STASYS-PES FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Linvatec Corp.. The 510(k) number is K934321.

When did LINVATEC STASYS-PES FIXATION DEVICE receive FDA 510(k) clearance?

LINVATEC STASYS-PES FIXATION DEVICE received FDA 510(k) clearance on 1995-05-10, under 510(k) number K934321.

Who is the listed applicant for LINVATEC STASYS-PES FIXATION DEVICE?

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

What is the FDA product code for LINVATEC STASYS-PES FIXATION DEVICE?

The FDA product code for LINVATEC STASYS-PES FIXATION DEVICE is HWC. This falls under the Cardiovascular category.

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Other records listing Linvatec Corp. 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.

K092998CONMED LINVATEC INTERCEPT IMPLANTK091549CONMED LINVATEC SOFT TISSUE TO BONE SYSTEMK090835CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CRK090186CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURESK083281EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-K060198MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

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Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, 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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