Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003
510(k) K043583
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043583 | Date26 Jan 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Charlotte Snap-Off Screw is a metallic orthopedic fixation device designed for bone fracture fixation and reconstruction in the foot and hand. It features self-drilling and self-tapping distal threads to simplify insertion into bone, providing mechanical stability to bone fragments or osteotomy sites.
This device is supplied sterile and intended for single-use in surgical settings. It is classified under product code HWC and has received FDA 510(k) clearance through the Special pathway, with a decision date of January 26, 2005. Models 45110001, 45110002, and 45110003 are included in the cleared submission.
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Questions
AI-generated answers, 19 Sep 2026
What types of procedures is the Charlotte Snap-Off Screw intended for in the foot and hand?
The Charlotte Snap-Off Screw is designed for bone fracture fixation and reconstruction in the foot and hand. Its self-drilling and self-tapping distal threads make it suitable for stabilizing bone fragments or osteotomy sites, ensuring mechanical stability during surgical procedures.
Are there different sizes or models available for the Charlotte Snap-Off Screw, and how do I choose the right one?
Yes, the Charlotte Snap-Off Screw comes in three distinct models: 45110001, 45110002, and 45110003. While the exact specifications for each model aren’t detailed here, the differences likely cater to varying clinical needs such as screw length, diameter, or thread pitch. Selection should be based on the specific anatomical requirements of the patient’s fracture or reconstruction site, ideally guided by surgical planning or manufacturer recommendations.
Is the Charlotte Snap-Off Screw reusable, or is it meant for single-use only?
The Charlotte Snap-Off Screw is explicitly intended for single-use in surgical settings. It is supplied sterile, which aligns with its design for one-time application to minimize infection risks and ensure optimal performance during the procedure.
How is the Charlotte Snap-Off Screw sterilized, and what storage instructions should I follow?
The device is supplied sterile, but specific sterilization methods (e.g., gamma radiation, ethylene oxide) aren’t detailed here. To maintain sterility, store the screws in their original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for re-sealing or handling if the packaging is opened prematurely.
What regulatory pathway was used for FDA clearance of the Charlotte Snap-Off Screw, and when was it approved?
The Charlotte Snap-Off Screw received FDA 510(k) clearance through the Special pathway, which is typically used for devices with well-established safety and effectiveness. The clearance was granted on January 26, 2005, under product code HWC (Orthopedic Devices). This pathway confirms the device was deemed substantially equivalent to a legally marketed predicate.