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FDA 510(k)

SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR

K-Number: K010690 · 2001-05-18

ApplicantSynthes (Usa)
Decision Date2001-05-18
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K010690. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR?

SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Synthes (Usa). The 510(k) number is K010690.

When did SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR receive FDA 510(k) clearance?

SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010690.

Who is the listed applicant for SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR?

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 TITANIUM MULTI-VECTOR DISTRACTOR?

The FDA product code for SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR is DZL.

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Other records listing Synthes (Usa) as applicant

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Related Devices (Code: DZL)

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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