Data / Medical devices / United States / Ortho Precision Products
Ortho Precision Products: FDA-registered device maker in Hawthorne, CA, United States, 8 510(k) clearances
Ortho Precision Products is registered with the FDA (registration 3011053036) in Hawthorne, CA, United States. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 14, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011053036
- Address
- 3201 W. El Segundo Blvd, Hawthorne, CA, United States, 90250
- Owner or operator
- Gamboa (10047394)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 21, 2014
- Registered through
- 2026
- Brand names listed
- Tiger Cannulated Screw System, Tiger Headless Cannulated Screw
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2016 | K153338 | Tiger Cannulated Screw System | HWC | Substantially Equivalent | Trilliant Surgical, Ltd. | accessdata.fda.gov |
| October 2, 2012 | K120148 | AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW | HSB | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| October 20, 2011 | K112737 | TIGER HEADLESS CANNULATED SCREWS | HWC | Substantially Equivalent | Trilliant Surgical, Ltd. | accessdata.fda.gov |
| January 19, 2011 | K103533 | ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM | HSB | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| June 14, 2007 | K070444 | AOS TIBIAL NAIL | HSB | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| March 14, 2005 | K050241 | AOS HUMERAL NAIL | HSB | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| June 20, 2002 | K021008 | ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL | HSB | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| September 24, 2001 | K012190 | AOS MODULAR FEMORAL NAIL | HSB | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 14, 2016. 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.