Data / Medical devices / United States / Subchondral Solutions
Subchondral Solutions: FDA-registered device maker in Costa Mesa, CA, United States, 3 510(k) clearances
Subchondral Solutions is registered with the FDA (registration 3016660811) in Costa Mesa, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016660811
- Address
- 1725 Monrovia Ave Suite C-5, Costa Mesa, CA, United States, 92627
- Owner or operator
- Subchondral Solutions (10062793)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 8, 2020
- Registered through
- 2026
- Brand names listed
- S-Core Delivery Instruments, S-Core HA Coated Implant, SCS UE Implant and Delivery System, SS Sports Implant and Delivery System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 29, 2022 | K220901 | S-Core Implant System | MBI | Substantially Equivalent | Subchondral Solutions, Inc. | accessdata.fda.gov |
| April 18, 2020 | K191995 | S4 Screw System | HWC | Substantially Equivalent | Subchondral Solutions, Inc. | accessdata.fda.gov |
| September 7, 2017 | K162171 | S4 Screw System | HWC | Substantially Equivalent | Subchondral Solutions | accessdata.fda.gov |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Screw, Fixation, Bone
- All makers of Orthopedic Manual Surgical Instrument
Updated July 29, 2022. 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.