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)

LACTOSORB SUTURE ANCHOR

K-Number: K954443 · 1996-01-31

ApplicantPoly-Medics,Inc.
Decision Date1996-01-31
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

LACTOSORB SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Poly-Medics,Inc.. It received FDA 510(k) clearance on 1996-01-31 under 510(k) number K954443. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the LACTOSORB SUTURE ANCHOR?

LACTOSORB SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1996-01-31. The listed applicant is Poly-Medics,Inc.. The 510(k) number is K954443.

When did LACTOSORB SUTURE ANCHOR receive FDA 510(k) clearance?

LACTOSORB SUTURE ANCHOR received FDA 510(k) clearance on 1996-01-31, under 510(k) number K954443.

Who is the listed applicant for LACTOSORB SUTURE ANCHOR?

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

What is the FDA product code for LACTOSORB SUTURE ANCHOR?

The FDA product code for LACTOSORB SUTURE ANCHOR 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.

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 Poly-Medics,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.

K960988LACTOSORB TRAUMA PLATING SYSTEMK955729LACTOSORB TRAUMA PLATING SYSTEMK951658LACTOSORB POP RIVETK934861HARD TISSUE REPLACEMENT (HTR) GRANULAR

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

View on FDA Database →

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

↑