(44 days)
I'm sorry, I cannot answer the question using the provided input as it says "Not Found." and does not contain the information needed to identify the K/DEN numbers.
Not Found.
No
The description focuses on the physical characteristics and intended use of titanium alloy screws for bone fixation, with no mention of software, image processing, or AI/ML terms.
Yes
The device is used for internal fixation of small bones, which is a therapeutic intervention to treat conditions like fractures or deformities.
No
Explanation: The provided text describes a system used for "internal fixation of small bones," consisting of titanium alloy screws. This is a therapeutic device, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions, which is not the stated purpose of this device.
No
The device description explicitly states it is a series of titanium alloy screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The provided description clearly states the device is a system of titanium alloy screws intended for internal fixation of bones. This means the device is implanted inside the body to stabilize fractures or perform reconstructive surgery.
The intended use and device description are consistent with a surgical implant, not a diagnostic test performed on a sample.
N/A
Not Found.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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510(k) SUMMARY
Device: Forefoot Reconstruction System
| Proprietary Name: | Forefoot Reconstruction System |
|---|---|
| Common Name: | Small Bone Screw System |
| Classification Name and Reference: | Single/Multiple Component Metallic Bone Fixation |
| Appliances and Accessories 888.3030 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87HRS 763EY |
| For information contact: | John Dichiara |
| Manager, Regulatory Affairs | |
| Howmedica Inc. | |
| 359 Veterans Boulevard | |
| Rutherford, NJ 07070 | |
| Telephone: (201)-507-7386 |
The Forefoot Reconstruction System is a series of Ti6A14V titanium alloy screws 2.3-3.0 mm in diameter and 8-22 mm in length. The system is intended for use in internal fixation of small bones including the foot, hand, craniofacial skeleton and midface. All screws are fully threaded and self-tapping with internal hex-drive heads.
The substantial equivalence of these devices is based on equivalence in intended use, design, materials and operating principles to several legally marketed devices including the Luhr Fixation System (Howmedica Inc.), the Alta Modular Trauma Small Bone Plating System (Howmedica Inc.) and the Synthes® Small Fragment and Mini Set (Synthes USA).