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FDA 510(k)

OsteoBullet Compression Screw

K-Number: K160304 · 2016-04-29

ApplicantPhalanx Innovations
Decision Date2016-04-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoBullet Compression Screw is the device name listed in this FDA 510(k) record. The listed applicant is Phalanx Innovations. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K160304. 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 OsteoBullet Compression Screw?

OsteoBullet Compression Screw is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Phalanx Innovations. The 510(k) number is K160304.

When did OsteoBullet Compression Screw receive FDA 510(k) clearance?

OsteoBullet Compression Screw received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160304.

Who is the listed applicant for OsteoBullet Compression Screw?

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

What is the FDA product code for OsteoBullet Compression Screw?

The FDA product code for OsteoBullet Compression Screw is HWC. This falls under the Cardiovascular category.

Other records listing Phalanx Innovations 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.

K160194StarFuse Interphalangeal Pin

Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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