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FDA 510(k)

IMPLEX CERAMIC HEAD

K-Number: K955117 · 1996-04-05

ApplicantImplex Corp.
Decision Date1996-04-05
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLEX CERAMIC HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1996-04-05 under 510(k) number K955117. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLEX CERAMIC HEAD?

IMPLEX CERAMIC HEAD is a medical device that received FDA 510(k) clearance on 1996-04-05. The listed applicant is Implex Corp.. The 510(k) number is K955117.

When did IMPLEX CERAMIC HEAD receive FDA 510(k) clearance?

IMPLEX CERAMIC HEAD received FDA 510(k) clearance on 1996-04-05, under 510(k) number K955117.

Who is the listed applicant for IMPLEX CERAMIC HEAD?

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

What is the FDA product code for IMPLEX CERAMIC HEAD?

The FDA product code for IMPLEX CERAMIC HEAD is LZO.

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Other records listing Implex Corp. 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.

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Related Devices (Code: LZO)

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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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