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FDA 510(k)

EIS THREADED SCREW FRACTURE FIXATION

K-Number: K991964 · 1999-12-20

ApplicantGroupe Lepine
Decision Date1999-12-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EIS THREADED SCREW FRACTURE FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Groupe Lepine. It received FDA 510(k) clearance on 1999-12-20 under 510(k) number K991964. 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 EIS THREADED SCREW FRACTURE FIXATION?

EIS THREADED SCREW FRACTURE FIXATION is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is Groupe Lepine. The 510(k) number is K991964.

When did EIS THREADED SCREW FRACTURE FIXATION receive FDA 510(k) clearance?

EIS THREADED SCREW FRACTURE FIXATION received FDA 510(k) clearance on 1999-12-20, under 510(k) number K991964.

Who is the listed applicant for EIS THREADED SCREW FRACTURE FIXATION?

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

What is the FDA product code for EIS THREADED SCREW FRACTURE FIXATION?

The FDA product code for EIS THREADED SCREW FRACTURE FIXATION is HWC. This falls under the Cardiovascular category.

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Other records listing Groupe Lepine 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.

K991962EIS DYNAMIC MEMORY STAPLES SYSTEM

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

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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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