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FDA 510(k)

ORTHOPLUG SOFT BONE DESIGN

K-Number: K955632 · 1996-02-27

ApplicantSunmed, Inc.
Decision Date1996-02-27
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORTHOPLUG SOFT BONE DESIGN is the device name listed in this FDA 510(k) record. The listed applicant is Sunmed, Inc.. It received FDA 510(k) clearance on 1996-02-27 under 510(k) number K955632. 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 ORTHOPLUG SOFT BONE DESIGN?

ORTHOPLUG SOFT BONE DESIGN is a medical device that received FDA 510(k) clearance on 1996-02-27. The listed applicant is Sunmed, Inc.. The 510(k) number is K955632.

When did ORTHOPLUG SOFT BONE DESIGN receive FDA 510(k) clearance?

ORTHOPLUG SOFT BONE DESIGN received FDA 510(k) clearance on 1996-02-27, under 510(k) number K955632.

Who is the listed applicant for ORTHOPLUG SOFT BONE DESIGN?

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

What is the FDA product code for ORTHOPLUG SOFT BONE DESIGN?

The FDA product code for ORTHOPLUG SOFT BONE DESIGN is LZN.

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 Sunmed, 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.

K062112SUNMED FOLEY CATHETERSK955631ORTHOPLUG HARD BONE DESIGNK921263SUNLITE LARYNGOSCOPE

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.K010840SYNPLUGIsotis NV

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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