Ultra Compression Screw System
K-Number: K251555 · 2025-11-06
ApplicantPace Surgical
Decision Date2025-11-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Ultra Compression Screw System is a medical device manufactured by Pace Surgical. It received FDA 510(k) clearance on 2025-11-06 under approval number K251555. 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 Ultra Compression Screw System?
Ultra Compression Screw System is a medical device that received FDA 510(k) clearance on 2025-11-06. It is manufactured by Pace Surgical. The 510(k) number is K251555.
When was Ultra Compression Screw System approved by the FDA?
Ultra Compression Screw System received FDA 510(k) clearance on 2025-11-06, under approval number K251555.
What company makes Ultra Compression Screw System?
Ultra Compression Screw System is manufactured by Pace Surgical.
What is the FDA product code for Ultra Compression Screw System?
The FDA product code for Ultra Compression Screw System 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.