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FDA 510(k)

SYNTHES USS (10.0MM SIDE OPENING SCREWS)

K-Number: K003061 · 2000-10-30

ApplicantSynthes
Decision Date2000-10-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES USS (10.0MM SIDE OPENING SCREWS) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes. It received FDA 510(k) clearance on 2000-10-30 under 510(k) number K003061. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES USS (10.0MM SIDE OPENING SCREWS)?

SYNTHES USS (10.0MM SIDE OPENING SCREWS) is a medical device that received FDA 510(k) clearance on 2000-10-30. The listed applicant is Synthes. The 510(k) number is K003061.

When did SYNTHES USS (10.0MM SIDE OPENING SCREWS) receive FDA 510(k) clearance?

SYNTHES USS (10.0MM SIDE OPENING SCREWS) received FDA 510(k) clearance on 2000-10-30, under 510(k) number K003061.

Who is the listed applicant for SYNTHES USS (10.0MM SIDE OPENING SCREWS)?

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

What is the FDA product code for SYNTHES USS (10.0MM SIDE OPENING SCREWS)?

The FDA product code for SYNTHES USS (10.0MM SIDE OPENING SCREWS) is KWQ.

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Other records listing Synthes 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.

K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMK122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMK113071SYNTHECEL DURA REPLACEMENT DEVICESK110604VBB SYSTEMK093772SYNTHES STERNAL FIXATION SYSTEMK013072CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

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Related Devices (Code: KWQ)

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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