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FDA 510(k)

SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION

K-Number: K964259 · 1997-01-09

ApplicantSynthes (Usa)
Decision Date1997-01-09
Product CodeJDO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1997-01-09 under 510(k) number K964259. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION?

SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is Synthes (Usa). The 510(k) number is K964259.

When did SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION receive FDA 510(k) clearance?

SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION received FDA 510(k) clearance on 1997-01-09, under 510(k) number K964259.

Who is the listed applicant for SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION?

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

What is the FDA product code for SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION?

The FDA product code for SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION is JDO.

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Other records listing Synthes (Usa) as applicant

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Related Devices (Code: JDO)

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.

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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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