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FDA 510(k)

AmorChem Titanium Porous Fixation Device

K-Number: K160791 · 2016-11-15

ApplicantAmorchem Holdings, Inc.
Decision Date2016-11-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AmorChem Titanium Porous Fixation Device is a medical device manufactured by Amorchem Holdings, Inc.. It received FDA 510(k) clearance on 2016-11-15 under approval number K160791. 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 AmorChem Titanium Porous Fixation Device?

AmorChem Titanium Porous Fixation Device is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Amorchem Holdings, Inc.. The 510(k) number is K160791.

When was AmorChem Titanium Porous Fixation Device approved by the FDA?

AmorChem Titanium Porous Fixation Device received FDA 510(k) clearance on 2016-11-15, under approval number K160791.

What company makes AmorChem Titanium Porous Fixation Device?

AmorChem Titanium Porous Fixation Device is manufactured by Amorchem Holdings, Inc..

What is the FDA product code for AmorChem Titanium Porous Fixation Device?

The FDA product code for AmorChem Titanium Porous Fixation Device is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Related Devices (Code: HWC)

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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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