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FDA 510(k)

SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)

K-Number: K812053 · 1981-08-18

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1981-08-18
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) 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 1981-08-18 under 510(k) number K812053. The device is classified under product code KXE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)?

SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) is a medical device that received FDA 510(k) clearance on 1981-08-18. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K812053.

When did SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) receive FDA 510(k) clearance?

SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) received FDA 510(k) clearance on 1981-08-18, under 510(k) number K812053.

Who is the listed applicant for SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)?

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 HEMI WRIST IMPLANT H.P. (RAD.)?

The FDA product code for SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) is KXE.

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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

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Related Devices (Code: KXE)

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.

K190599Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLCK112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension OrthopedicK081025ISOELASTICURemi Sciences, Inc.K082839DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLCK061146SBI ULNAR HEAD IMPLANTSmall Bone Innovations, Inc.K053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC

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.

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