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)

FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER

K-Number: K852026 · 1985-05-22

ApplicantWarsaw Orthopedic, Inc.
Decision Date1985-05-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER is the device name listed in this FDA 510(k) record. The listed applicant is Warsaw Orthopedic, Inc.. It received FDA 510(k) clearance on 1985-05-22 under 510(k) number K852026. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER?

FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER is a medical device that received FDA 510(k) clearance on 1985-05-22. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K852026.

When did FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER receive FDA 510(k) clearance?

FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER received FDA 510(k) clearance on 1985-05-22, under 510(k) number K852026.

Who is the listed applicant for FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER?

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

What is the FDA product code for FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER?

The FDA product code for FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER is HWC. This falls under the Cardiovascular category.

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 Warsaw Orthopedic, 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.

K892877CRADLE, HOSPITAL BED CLOTHINGK883783TSRH SACRAL SPINAL SCREWK883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATEK880211TSRH H/M HOOK HOLDERK880212TSRH H/M HOOK HOLDER W/ROD MOVERK880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD

View all 24 devices →

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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.

↑