Data / Medical devices / United States / Forma Medical, Inc.
Forma Medical, Inc.: FDA-registered device maker in Camp Hill, PA, United States, 2 510(k) clearances
Forma Medical, Inc. is registered with the FDA (registration 3027760323) in Camp Hill, PA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027760323
- Address
- 3401 Hartzdale Drive Suite 103B Unit 611, Camp Hill, PA, United States, 17011
- Owner or operator
- Forma Medical (10088505)
- Roles
- Specification developer
- First device listed
- August 3, 2023
- Registered through
- 2027
- Brand names listed
- Optimal Plating System, OptimalHT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | 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 |
|---|---|---|---|---|---|---|
| June 26, 2024 | K234059 | Forma Medical Optimal Plating System | HRS | Substantially Equivalent | Forma Medical, Inc. | accessdata.fda.gov |
| July 18, 2023 | K230945 | Forma Medical Headless Compression Screw | HWC | Substantially Equivalent | Forma Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 26, 2024. 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.