Data / Medical devices / Accessories, Fixation, Spinal Intervertebral Body
Accessories, Fixation, Spinal Intervertebral Body (LYQ): 17 FDA-registered makers in 7 countries
17 establishments in 7 countries are registered with the FDA to make Accessories, Fixation, Spinal Intervertebral Body (product code LYQ, Class 1, 21 CFR 888.4540). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on June 7, 1989, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LYQ
- Device class
- 1
- Regulation
- 888.4540
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| India | 3 |
| South Korea | 1 |
| Turkey | 1 |
| Egypt | 1 |
| China | 1 |
| Pakistan | 1 |
Makers of Accessories, Fixation, Spinal Intervertebral Body
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Corentec Co., Ltd. | Cheonan Si, Chungnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flospine LLC | Boca Raton, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happe Spine | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HC Biologics LLC | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indius Medical Technologies Pvt. Ltd. | Pune Maharashtra, India | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mikron Makina Sanayi Ve Ticaret Ltd. Sti. | Ivedik Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteomni Inc | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Instruments Inc. | Honolulu, HI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Solutions, LLC | Brunswick, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pioneer Surgical Technology, Inc. | Marquette, MI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Medical Instruments (group) Ltd. Corp. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solco Biomedical Company India Private Limited | KADI Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stone Instruments Co. | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vy Spine, LLC | Bountiful, UT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenix Medical | Orlando, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 7, 1989. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.