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)

PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)

K-Number: K091011 · 2009-04-22

ApplicantSurgical Technology Laboratories, Inc ("Stl")
Decision Date2009-04-22
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technology Laboratories, Inc ("Stl"). It received FDA 510(k) clearance on 2009-04-22 under 510(k) number K091011. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)?

PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) is a medical device that received FDA 510(k) clearance on 2009-04-22. The listed applicant is Surgical Technology Laboratories, Inc ("Stl"). The 510(k) number is K091011.

When did PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) receive FDA 510(k) clearance?

PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) received FDA 510(k) clearance on 2009-04-22, under 510(k) number K091011.

Who is the listed applicant for PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)?

The FDA 510(k) record lists Surgical Technology Laboratories, Inc ("Stl") as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)?

The FDA product code for PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) is FWP.

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

Related Devices (Code: FWP)

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.

K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KGK232593FITme Customized Silicone ImplantKeosan Trading Co.K200610Customized Contour ImplantImplantech Associates, Inc.K191130Customized Contour ImplantImplantech Associates, Inc.K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KGK153508Stryker CMF MEDPOR Customized ImplantStryker

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.

↑