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FDA 510(k)

RADIX CERVICAL PLATE

K-Number: K033951 · 2004-07-01

ApplicantPisharodi Surgicals, Inc.
Decision Date2004-07-01
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RADIX CERVICAL PLATE 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 2004-07-01 under 510(k) number K033951. 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 RADIX CERVICAL PLATE?

RADIX CERVICAL PLATE is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Pisharodi Surgicals, Inc.. The 510(k) number is K033951.

When did RADIX CERVICAL PLATE receive FDA 510(k) clearance?

RADIX CERVICAL PLATE received FDA 510(k) clearance on 2004-07-01, under 510(k) number K033951.

Who is the listed applicant for RADIX CERVICAL PLATE?

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 RADIX CERVICAL PLATE?

The FDA product code for RADIX CERVICAL PLATE is KWQ.

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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.

K070335SIMPLEX CERVICAL FIXATION SYSTEMK024313MODIFICATION 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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