ALLY(TM) Bone Screws
K-Number: K170698 · 2017-05-31
ApplicantProvidence Medical Technology, Inc.
Decision Date2017-05-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ALLY(TM) Bone Screws is a medical device manufactured by Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2017-05-31 under approval number K170698. 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 ALLY(TM) Bone Screws?
ALLY(TM) Bone Screws is a medical device that received FDA 510(k) clearance on 2017-05-31. It is manufactured by Providence Medical Technology, Inc.. The 510(k) number is K170698.
When was ALLY(TM) Bone Screws approved by the FDA?
ALLY(TM) Bone Screws received FDA 510(k) clearance on 2017-05-31, under approval number K170698.
What company makes ALLY(TM) Bone Screws?
ALLY(TM) Bone Screws is manufactured by Providence Medical Technology, Inc..
What is the FDA product code for ALLY(TM) Bone Screws?
The FDA product code for ALLY(TM) Bone Screws 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.