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Ace 6.5 mm Bone Screw

FDA 510(k)

Class II (US FDA 510(k))

510(k) K931652

by Ace Medical Co.

Identifiers

510(k) Number
K931652 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SN FDA 510(k)

The Ace 6.5 mm Bone Screw is an orthopedic device designed for bone fixation. It is intended for use in orthopedic procedures to provide stabilization.

This device is supplied under FDA 510(k) clearance K931652. It is categorized under the orthopedic advisory committee.

Frequently asked questions

What is the primary purpose of the ACE 6.5 mm Bone Screw?

This device is specifically designed for orthopedic procedures to provide bone fixation and stabilization. It is intended to assist in maintaining the position of bone segments during the healing process.

Under what regulatory authorization is this device supplied?

The ACE 6.5 mm Bone Screw is supplied under FDA 510(k) clearance number K931652. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices for specific orthopedic indications.

Which medical specialty is this bone screw intended for?

The device is categorized under the orthopedic advisory committee. It is intended for use by clinicians performing orthopedic surgeries where bone fixation is required for patient stabilization.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ACE 6.5 MM BONE SCREW (K931652) — FDA 510 (k) | Innolitics, Ace - allmed.wiki, Ace 6.5 mm/8.0 mm Cannulated Screw System set

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ace Medical Co.

Sources (1)

  • FDA 510(k) K931652 24 fields · synced Sep 26, 2026