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FDA 510(k)

SILKON STAINLESS STEEL CABLE SYSTEM

K-Number: K962132 · 1996-08-08

ApplicantOsteonics Corp.
Decision Date1996-08-08
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SILKON STAINLESS STEEL CABLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1996-08-08 under 510(k) number K962132. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILKON STAINLESS STEEL CABLE SYSTEM?

SILKON STAINLESS STEEL CABLE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-08. The listed applicant is Osteonics Corp.. The 510(k) number is K962132.

When did SILKON STAINLESS STEEL CABLE SYSTEM receive FDA 510(k) clearance?

SILKON STAINLESS STEEL CABLE SYSTEM received FDA 510(k) clearance on 1996-08-08, under 510(k) number K962132.

Who is the listed applicant for SILKON STAINLESS STEEL CABLE SYSTEM?

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

What is the FDA product code for SILKON STAINLESS STEEL CABLE SYSTEM?

The FDA product code for SILKON STAINLESS STEEL CABLE SYSTEM is JDQ.

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Other records listing Osteonics 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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Related Devices (Code: JDQ)

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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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