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FDA 510(k)

SCAPHIX, STAPLE, FIXATION, BONE

K-Number: K003033 · 2001-05-30

ApplicantAvanta Orthopaedics, Inc.
Decision Date2001-05-30
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCAPHIX, STAPLE, FIXATION, BONE is the device name listed in this FDA 510(k) record. The listed applicant is Avanta Orthopaedics, Inc.. It received FDA 510(k) clearance on 2001-05-30 under 510(k) number K003033. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCAPHIX, STAPLE, FIXATION, BONE?

SCAPHIX, STAPLE, FIXATION, BONE is a medical device that received FDA 510(k) clearance on 2001-05-30. The listed applicant is Avanta Orthopaedics, Inc.. The 510(k) number is K003033.

When did SCAPHIX, STAPLE, FIXATION, BONE receive FDA 510(k) clearance?

SCAPHIX, STAPLE, FIXATION, BONE received FDA 510(k) clearance on 2001-05-30, under 510(k) number K003033.

Who is the listed applicant for SCAPHIX, STAPLE, FIXATION, BONE?

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

What is the FDA product code for SCAPHIX, STAPLE, FIXATION, BONE?

The FDA product code for SCAPHIX, STAPLE, FIXATION, BONE is JDR.

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Other records listing Avanta Orthopaedics, Inc. as applicant

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Related Devices (Code: JDR)

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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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