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FDA 510(k)

EIS DYNAMIC MEMORY STAPLES SYSTEM

K-Number: K991962 · 2000-01-10

ApplicantGroupe Lepine
Decision Date2000-01-10
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EIS DYNAMIC MEMORY STAPLES SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Groupe Lepine. It received FDA 510(k) clearance on 2000-01-10 under 510(k) number K991962. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EIS DYNAMIC MEMORY STAPLES SYSTEM?

EIS DYNAMIC MEMORY STAPLES SYSTEM is a medical device that received FDA 510(k) clearance on 2000-01-10. The listed applicant is Groupe Lepine. The 510(k) number is K991962.

When did EIS DYNAMIC MEMORY STAPLES SYSTEM receive FDA 510(k) clearance?

EIS DYNAMIC MEMORY STAPLES SYSTEM received FDA 510(k) clearance on 2000-01-10, under 510(k) number K991962.

Who is the listed applicant for EIS DYNAMIC MEMORY STAPLES SYSTEM?

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 DYNAMIC MEMORY STAPLES SYSTEM?

The FDA product code for EIS DYNAMIC MEMORY STAPLES SYSTEM is JDR.

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 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.

K991964EIS THREADED SCREW FRACTURE FIXATION

Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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