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FDA 510(k)

SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)

K-Number: K050607 · 2005-04-11

ApplicantSynthes (Usa)
Decision Date2005-04-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2005-04-11 under 510(k) number K050607. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)?

SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) is a medical device that received FDA 510(k) clearance on 2005-04-11. The listed applicant is Synthes (Usa). The 510(k) number is K050607.

When did SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) receive FDA 510(k) clearance?

SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) received FDA 510(k) clearance on 2005-04-11, under 510(k) number K050607.

Who is the listed applicant for SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)?

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 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)?

The FDA product code for SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) is HRS.

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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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