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FDA 510(k)

SYNTHES 90 DEGREE SCREWDRIVER

K-Number: K082649 · 2009-04-30

ApplicantSynthes (Usa)
Decision Date2009-04-30
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHES 90 DEGREE SCREWDRIVER is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2009-04-30 under 510(k) number K082649. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES 90 DEGREE SCREWDRIVER?

SYNTHES 90 DEGREE SCREWDRIVER is a medical device that received FDA 510(k) clearance on 2009-04-30. The listed applicant is Synthes (Usa). The 510(k) number is K082649.

When did SYNTHES 90 DEGREE SCREWDRIVER receive FDA 510(k) clearance?

SYNTHES 90 DEGREE SCREWDRIVER received FDA 510(k) clearance on 2009-04-30, under 510(k) number K082649.

Who is the listed applicant for SYNTHES 90 DEGREE SCREWDRIVER?

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 90 DEGREE SCREWDRIVER?

The FDA product code for SYNTHES 90 DEGREE SCREWDRIVER is DZI.

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Other records listing Synthes (Usa) as applicant

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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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