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FDA 510(k)

HEADLOC CERAMIC HEAD

K-Number: K970675 · 1997-08-22

ApplicantOrtho Development Corp.
Decision Date1997-08-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEADLOC CERAMIC HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 1997-08-22 under 510(k) number K970675. 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 HEADLOC CERAMIC HEAD?

HEADLOC CERAMIC HEAD is a medical device that received FDA 510(k) clearance on 1997-08-22. The listed applicant is Ortho Development Corp.. The 510(k) number is K970675.

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

HEADLOC CERAMIC HEAD received FDA 510(k) clearance on 1997-08-22, under 510(k) number K970675.

Who is the listed applicant for HEADLOC CERAMIC HEAD?

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

What is the FDA product code for HEADLOC CERAMIC HEAD?

The FDA product code for HEADLOC CERAMIC HEAD is LZO.

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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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