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FDA 510(k)

SYNPLUG

K-Number: K010840 · 2001-04-20

ApplicantIsotis NV
Decision Date2001-04-20
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNPLUG is the device name listed in this FDA 510(k) record. The listed applicant is Isotis NV. It received FDA 510(k) clearance on 2001-04-20 under 510(k) number K010840. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNPLUG?

SYNPLUG is a medical device that received FDA 510(k) clearance on 2001-04-20. The listed applicant is Isotis NV. The 510(k) number is K010840.

When did SYNPLUG receive FDA 510(k) clearance?

SYNPLUG received FDA 510(k) clearance on 2001-04-20, under 510(k) number K010840.

Who is the listed applicant for SYNPLUG?

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

What is the FDA product code for SYNPLUG?

The FDA product code for SYNPLUG is LZN.

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Other records listing Isotis NV as applicant

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Related Devices (Code: LZN)

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.

K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker OrthopaedicsK061824TORNIER CEMENT RESTRICTORTornierK032685CEMSTOP CEMENT RESTRICTORTeknimed, S.A.K023680BIOBUCK CEMENT RESTRICTORSmith & Nephew, Inc.K011943IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTORKensey Nash Corp.K000587SHUTTLE STOPIsotis NV

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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