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)

SILASTIC H.P. TRAPEXIAL IMPLANT

K-Number: K781756 · 1978-11-15

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1978-11-15
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SILASTIC H.P. TRAPEXIAL IMPLANT 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 1978-11-15 under 510(k) number K781756. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILASTIC H.P. TRAPEXIAL IMPLANT?

SILASTIC H.P. TRAPEXIAL IMPLANT is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K781756.

When did SILASTIC H.P. TRAPEXIAL IMPLANT receive FDA 510(k) clearance?

SILASTIC H.P. TRAPEXIAL IMPLANT received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781756.

Who is the listed applicant for SILASTIC H.P. TRAPEXIAL IMPLANT?

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 SILASTIC H.P. TRAPEXIAL IMPLANT?

The FDA product code for SILASTIC H.P. TRAPEXIAL IMPLANT is KYI.

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: KYI)

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.

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLCK180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLCK111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLCK112278ASCENSION NUGRIP CMC IMPLANTAscension OrthopedicK092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLCK061956ARTELON STT SPACERArtimplant AB

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.

↑