FDA 510(k)

ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA

K-Number: K992512 · 1999-11-01

ApplicantImcor

Decision Date1999-11-01

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA is the device name listed in this FDA 510(k) record. The listed applicant is Imcor. It received FDA 510(k) clearance on 1999-11-01 under 510(k) number K992512. 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 ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA?

ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA is a medical device that received FDA 510(k) clearance on 1999-11-01. The listed applicant is Imcor. The 510(k) number is K992512.

When did ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA receive FDA 510(k) clearance?

ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA received FDA 510(k) clearance on 1999-11-01, under 510(k) number K992512.

Who is the listed applicant for ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA?

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

What is the FDA product code for ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA?

The FDA product code for ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA is DZE.

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Other records listing Imcor as applicant

K983563IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I K982492IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES K974126IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW K973049IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM K960899IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW K960900IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW

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Related Devices (Code: DZE)

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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.