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FDA 510(k)

SUTTER HAMMERTOE JOINT PROSTHESIS

K-Number: K943354 · 1995-06-12

ApplicantSutter Corp.
Decision Date1995-06-12
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUTTER HAMMERTOE JOINT PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Corp.. It received FDA 510(k) clearance on 1995-06-12 under 510(k) number K943354. 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 SUTTER HAMMERTOE JOINT PROSTHESIS?

SUTTER HAMMERTOE JOINT PROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-06-12. The listed applicant is Sutter Corp.. The 510(k) number is K943354.

When did SUTTER HAMMERTOE JOINT PROSTHESIS receive FDA 510(k) clearance?

SUTTER HAMMERTOE JOINT PROSTHESIS received FDA 510(k) clearance on 1995-06-12, under 510(k) number K943354.

Who is the listed applicant for SUTTER HAMMERTOE JOINT PROSTHESIS?

The FDA 510(k) record lists Sutter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUTTER HAMMERTOE JOINT PROSTHESIS?

The FDA product code for SUTTER HAMMERTOE JOINT PROSTHESIS is KWH.

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Other records listing Sutter Corp. 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.

K945221SUTTER MODEL 6000 HAND CPM DEVICEK931588SUTTER PROXIMAL INTERPHALANGEAL JOINTK924654FIRST METATARSOPHALANGEAL JOINT MOTION SPLINTK914860SUTTER MODEL 10000 LEG CPM DEVICEK902707MODEL 9000 AT ANKLE CPM DEVICEK890607SUTTER HOSPITAL CPM

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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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