# Osteomni Inc (specification developer, Miami, FL): 5 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Osteomni Inc |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Miami, FL, US |
| New listings | 5 |
| Devices | Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Bone Graft, Lumbar; Spinal Vertebral Body Replacement Device; Intervertebral Fusion Device With Integrated Fixation, Cervical; Spinal Vertebral Body Replacement Device - Cervical |
| Product codes | ODP, MAX, MQP, OVE, PLR |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | OMBC3211 OSTEOMNI TLIF PEEKCAGE 32X10X11MM; OCLA203244 OSTEOMNI LUMBAR CORPECTOMY CAGE 20X32X44 MM; OMEPC1007-Ti OSTEOMNI EXPANDABLE PLIF Ti CAGE 24X10X7 MM; OMCPCS091212-Ti OSTEOMNI CERVICAL Ti CAGE SINGLE 4.5X12X14 MM; OCLA284258 OSTEOMNI LUMBAR CORPECTOMY CAGE 28X42X58 MM 6° ANGLE; OCTC163965 OSTEOMNI CERVICAL CORPECTOMY CAGE 16X39X65 MM; OCLC204258 OSTEOMNI LUMBAR CORPECTOMY CAGE 20X42X58 MM; OMBC2811-Ti OSTEOMNI TLIF Ti CAGE 28X10X11MM |
| First new listing | 2026-05-22 |
| Latest new listing | 2026-05-22 |
| FDA registration number | 3041915189 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.