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FDA 510(k)

SIMPLEX CERVICAL FIXATION SYSTEM

K-Number: K070335 · 2007-04-16

ApplicantPisharodi Surgicals, Inc.
Decision Date2007-04-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIMPLEX CERVICAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pisharodi Surgicals, Inc.. It received FDA 510(k) clearance on 2007-04-16 under 510(k) number K070335. 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 SIMPLEX CERVICAL FIXATION SYSTEM?

SIMPLEX CERVICAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-16. The listed applicant is Pisharodi Surgicals, Inc.. The 510(k) number is K070335.

When did SIMPLEX CERVICAL FIXATION SYSTEM receive FDA 510(k) clearance?

SIMPLEX CERVICAL FIXATION SYSTEM received FDA 510(k) clearance on 2007-04-16, under 510(k) number K070335.

Who is the listed applicant for SIMPLEX CERVICAL FIXATION SYSTEM?

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

What is the FDA product code for SIMPLEX CERVICAL FIXATION SYSTEM?

The FDA product code for SIMPLEX CERVICAL FIXATION SYSTEM is KWQ.

Related Clinical Trials

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Other records listing Pisharodi Surgicals, Inc. 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.

K033951RADIX CERVICAL PLATEK024313MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEMK014302UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM

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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