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FDA 510(k)

SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL

K-Number: K801094 · 1980-06-09

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1980-06-09
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL 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 1980-06-09 under 510(k) number K801094. 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 SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL?

SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K801094.

When did SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL receive FDA 510(k) clearance?

SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801094.

Who is the listed applicant for SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL?

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 HAMMERTOE IMPLANT (SWANSON-WELL?

The FDA product code for SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL is KWH.

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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: 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.

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