Screwdriver, Surgical
The Surgical Screwdriver is a manual hand instrument used during orthopedic, spinal, or other surgical procedures to insert, tighten, or remove bone screws and fixation hardware. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRZ, regulated under 21 CFR 878.4800, within the General and Plastic Surgery medical specialty. No special flags apply to this device.
Research product code LRZ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- LRZ
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896589 | MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP | Dec 27, 1989 | Substantially Equivalent | Optik |
| K872490 | 1.1 SCREWDRIVERS | Jul 23, 1987 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K872387 | STANDARD SCREW DRIVER | Jul 16, 1987 | Substantially Equivalent | Med-Tool, Inc. |
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.