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 a medical device manufactured by Phalanx Innovations. It received FDA 510(k) clearance on 2016-04-29 under approval 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. It is manufactured by Phalanx Innovations. The 510(k) number is K160304.
When was OsteoBullet Compression Screw approved by the FDA?
OsteoBullet Compression Screw received FDA 510(k) clearance on 2016-04-29, under approval number K160304.
What company makes OsteoBullet Compression Screw?
OsteoBullet Compression Screw is manufactured by Phalanx Innovations.
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.
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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.