Accessories, Fixation, Spinal Intervertebral Body
The Spinal Intervertebral Body Fixation Accessories (product code LYQ) are orthopedic surgical instruments and non-implantable components used during spinal intervertebral body fixation procedures, such as interbody fusion surgery, to assist with device placement and alignment. Regulated under 21 CFR 888.4540 and classified as a Class 1 device subject only to general controls, they fall under the Orthopedic specialty. They are not flagged as implants and are not life-sustaining.
Research product code LYQ 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
- LYQ
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- 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 |
|---|---|---|---|---|
| K893415 | TRANS-ORAL DEPTH GAUGE | Jun 07, 1989 | Substantially Equivalent | Ruggles Corp. |
| K883784 | TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE | Apr 06, 1989 | Substantially Equivalent for Some Indications | Warsaw Orthopedic, Inc. |
| K882871 | CASF DRILL GUIDE DG 170 | Sep 23, 1988 | Substantially Equivalent for Some Indications | Terray Manufacturing, Inc. |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.