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)

SILASTIC INFLATABLE BONE PLUG H.P.

K-Number: K853186 · 1985-09-24

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1985-09-24
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILASTIC INFLATABLE BONE PLUG H.P. is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. It received FDA 510(k) clearance on 1985-09-24 under 510(k) number K853186. 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 SILASTIC INFLATABLE BONE PLUG H.P.?

SILASTIC INFLATABLE BONE PLUG H.P. is a medical device that received FDA 510(k) clearance on 1985-09-24. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K853186.

When did SILASTIC INFLATABLE BONE PLUG H.P. receive FDA 510(k) clearance?

SILASTIC INFLATABLE BONE PLUG H.P. received FDA 510(k) clearance on 1985-09-24, under 510(k) number K853186.

Who is the listed applicant for SILASTIC INFLATABLE BONE PLUG H.P.?

The FDA 510(k) record lists Dow Corning Corp. Healthcare Industries Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILASTIC INFLATABLE BONE PLUG H.P.?

The FDA product code for SILASTIC INFLATABLE BONE PLUG H.P. 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 Dow Corning Corp. Healthcare Industries Materials 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.

K844637WHITESIDE ACRYLIC CEMENT SPACER SLEEVEK850255DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMETK843995TF-II HIP PROSTHESISK842559WHITESIDE ORTHOLOC TOTAL HIP FEMORALK840357SSA HIP PROSTHESISK831479METAL-BACKED ACETABULAR CUP

View all 31 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.

↑