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FDA 510(k)

ALLOFIX PUSH-IN ANCHOR

K-Number: K070347 · 2007-05-11

ApplicantMusculoskeletal Transplant Foundation
Decision Date2007-05-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALLOFIX PUSH-IN ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Musculoskeletal Transplant Foundation. It received FDA 510(k) clearance on 2007-05-11 under 510(k) number K070347. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLOFIX PUSH-IN ANCHOR?

ALLOFIX PUSH-IN ANCHOR is a medical device that received FDA 510(k) clearance on 2007-05-11. The listed applicant is Musculoskeletal Transplant Foundation. The 510(k) number is K070347.

When did ALLOFIX PUSH-IN ANCHOR receive FDA 510(k) clearance?

ALLOFIX PUSH-IN ANCHOR received FDA 510(k) clearance on 2007-05-11, under 510(k) number K070347.

Who is the listed applicant for ALLOFIX PUSH-IN ANCHOR?

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

What is the FDA product code for ALLOFIX PUSH-IN ANCHOR?

The FDA product code for ALLOFIX PUSH-IN ANCHOR is HWC. This falls under the Cardiovascular category.

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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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