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FDA 510(k)

ISOROD PD-103 IMPLANT, MODEL ATI-PD-103

K-Number: K020683 · 2002-12-17

ApplicantAti Medical, Inc.
Decision Date2002-12-17
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 is the device name listed in this FDA 510(k) record. The listed applicant is Ati Medical, Inc.. It received FDA 510(k) clearance on 2002-12-17 under 510(k) number K020683. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOROD PD-103 IMPLANT, MODEL ATI-PD-103?

ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Ati Medical, Inc.. The 510(k) number is K020683.

When did ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 receive FDA 510(k) clearance?

ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 received FDA 510(k) clearance on 2002-12-17, under 510(k) number K020683.

Who is the listed applicant for ISOROD PD-103 IMPLANT, MODEL ATI-PD-103?

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

What is the FDA product code for ISOROD PD-103 IMPLANT, MODEL ATI-PD-103?

The FDA product code for ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 is KXK.

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Other records listing Ati Medical, 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.

K910026ATI MEDICAL COMFORT PLUS CPM PAD

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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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