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FDA 510(k)

SUTTER PROXIMAL INTERPHALANGEAL JOINT

K-Number: K931588 · 1994-03-10

ApplicantSutter Corp.
Decision Date1994-03-10
Product CodeKYJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUTTER PROXIMAL INTERPHALANGEAL JOINT is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Corp.. It received FDA 510(k) clearance on 1994-03-10 under 510(k) number K931588. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTTER PROXIMAL INTERPHALANGEAL JOINT?

SUTTER PROXIMAL INTERPHALANGEAL JOINT is a medical device that received FDA 510(k) clearance on 1994-03-10. The listed applicant is Sutter Corp.. The 510(k) number is K931588.

When did SUTTER PROXIMAL INTERPHALANGEAL JOINT receive FDA 510(k) clearance?

SUTTER PROXIMAL INTERPHALANGEAL JOINT received FDA 510(k) clearance on 1994-03-10, under 510(k) number K931588.

Who is the listed applicant for SUTTER PROXIMAL INTERPHALANGEAL JOINT?

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 PROXIMAL INTERPHALANGEAL JOINT?

The FDA product code for SUTTER PROXIMAL INTERPHALANGEAL JOINT is KYJ.

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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.

K943354SUTTER HAMMERTOE JOINT PROSTHESISK945221SUTTER MODEL 6000 HAND CPM DEVICEK924654FIRST METATARSOPHALANGEAL JOINT MOTION SPLINTK914860SUTTER MODEL 10000 LEG CPM DEVICEK902707MODEL 9000 AT ANKLE CPM DEVICEK890607SUTTER HOSPITAL CPM

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Related Devices (Code: KYJ)

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.

K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc.K220142BRM Digitalis SpacerBrm Extremities SrlK211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SAK083107MODIFICATION TO DEPUY NEUFLEX PIP FINGERDePuy Orthopaedics, Inc.K082231ASCENSION SILICONE PIPAscension Orthopedics, Inc.K022892ASCENSION SILLICONE MCPAscension 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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