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)

FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)

K-Number: K910547 · 1991-04-12

ApplicantTurnkey Intergration USA, Inc.
Decision Date1991-04-12
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1991-04-12 under 510(k) number K910547. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)?

FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K910547.

When did FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) receive FDA 510(k) clearance?

FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) received FDA 510(k) clearance on 1991-04-12, under 510(k) number K910547.

Who is the listed applicant for FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)?

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

What is the FDA product code for FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)?

The FDA product code for FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) is LZO.

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 Turnkey Intergration USA, 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.

K991405OMNI-FIX, HUMERAL NAILK990523B2C, ESPACE REVISION CUP SYSTEMK990307OMNI-FIX, NAIL SYSTEMK972411LINK CEMENT PLUGK970284ARTOS, DIPLOS SYSTEMK970084LINK CERCLAGE WIRE SYSTEM

View all 26 devices →

Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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.

↑