Data / Medical devices / United States / Osteomni Inc
Osteomni Inc: FDA-registered device maker in Miami, FL, United States, 2 510(k) clearances
Osteomni Inc is registered with the FDA (registration 3041915189) in Miami, FL, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3041915189
- Address
- 3402 NW 73RD ST. Ste# 3 Miami, FL 33147 Us, Miami, FL, United States, 33147
- Owner or operator
- OSTEOMNI INC (10094447)
- Roles
- Specification developer
- First device listed
- December 1, 2025
- Registered through
- 2026
- Brand names listed
- OCLA202534 OSTEOMNI LUMBAR CORPECTOMY CAGE 20X25X34 MM, OCLA203244 OSTEOMNI LUMBAR CORPECTOMY CAGE 20X32X44 MM, OCLA204258 OSTEOMNI LUMBAR CORPECTOMY CAGE 20X42X58 MM, OCLA205684 OSTEOMNI LUMBAR CORPECTOMY CAGE 20X56X84 MM, OCLA242329 OSTEOMNI LUMBAR CORPECTOMY CAGE 24X23X29 MM, OCLA242840 OSTEOMNI LUMBAR CORPECTOMY CAGE 24X28X40 MM, OCLA243854 OSTEOMNI LUMBAR CORPECTOMY CAGE 24X38X54 MM, OCLA245276 OSTEOMNI LUMBAR CORPECTOMY CAGE 24X52X76 MM 6° ANGLE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | 1 | Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | 2 | Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 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 |
|---|---|---|---|---|---|---|
| May 12, 2026 | K260850 | OSTEOMNI SPINAL CAGES SYSTEM | ODP | Substantially Equivalent | Osteomni, Inc. | accessdata.fda.gov |
| February 24, 2026 | K254247 | OSTEOMNI SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Osteomni, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Fixation, Spinal Intervertebral Body
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Spinal Vertebral Body Replacement Device
Updated May 12, 2026. 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.