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)

IMPLANT, HINGE TOE, FLEX.

K-Number: K780132 · 1978-02-06

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1978-02-06
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLANT, HINGE TOE, FLEX. 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 1978-02-06 under 510(k) number K780132. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANT, HINGE TOE, FLEX.?

IMPLANT, HINGE TOE, FLEX. is a medical device that received FDA 510(k) clearance on 1978-02-06. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K780132.

When did IMPLANT, HINGE TOE, FLEX. receive FDA 510(k) clearance?

IMPLANT, HINGE TOE, FLEX. received FDA 510(k) clearance on 1978-02-06, under 510(k) number K780132.

Who is the listed applicant for IMPLANT, HINGE TOE, FLEX.?

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 IMPLANT, HINGE TOE, FLEX.?

The FDA product code for IMPLANT, HINGE TOE, FLEX. is KWH.

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.

K853186SILASTIC INFLATABLE BONE PLUG H.P.K844637WHITESIDE ACRYLIC CEMENT SPACER SLEEVEK850255DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMETK843995TF-II HIP PROSTHESISK842559WHITESIDE ORTHOLOC TOTAL HIP FEMORALK840357SSA HIP PROSTHESIS

View all 31 devices →

Related Devices (Code: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK190136Fusion Silastic SystemFusion Orthopedics, LLCK173491RTS Lesser MTP Implant SystemIn2bones USA, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLCK102601ORTHOFLEX RODOrtho-Pro, LLCK023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNexa Orthopedics, 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.

↑