Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RESORABPLUG

K-Number: K920118 · 1993-02-08

ApplicantSofamor Danek Mfg., Inc.
Decision Date1993-02-08
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESORABPLUG is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek Mfg., Inc.. It received FDA 510(k) clearance on 1993-02-08 under 510(k) number K920118. 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 RESORABPLUG?

RESORABPLUG is a medical device that received FDA 510(k) clearance on 1993-02-08. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K920118.

When did RESORABPLUG receive FDA 510(k) clearance?

RESORABPLUG received FDA 510(k) clearance on 1993-02-08, under 510(k) number K920118.

Who is the listed applicant for RESORABPLUG?

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

What is the FDA product code for RESORABPLUG?

The FDA product code for RESORABPLUG 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sofamor Danek Mfg., 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.

K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMSK930191DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SYK932029TSRH SPINAL SCREWSK922486DANEK TISSUE CUTTING AND REMOVAL SYSTEMK930807SENTRY ANTERIOR SPINAL SYSTEMK930710SENTRY POSTERIOR SPINAL SYSTEM

View all 23 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑