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FDA 510(k)

HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II

K-Number: K924112 · 1994-07-12

ApplicantSaber Technology, Inc.
Decision Date1994-07-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II is the device name listed in this FDA 510(k) record. The listed applicant is Saber Technology, Inc.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K924112. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II?

HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Saber Technology, Inc.. The 510(k) number is K924112.

When did HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II receive FDA 510(k) clearance?

HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II received FDA 510(k) clearance on 1994-07-12, under 510(k) number K924112.

Who is the listed applicant for HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II?

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

What is the FDA product code for HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II?

The FDA product code for HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II is DZE.

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Other records listing Saber Technology, 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.

K882226SERIES I AND II IMPLANTS

Related Devices (Code: DZE)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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