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

Osteomni Inc (Miami, Florida): 5 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical. Its amount of 5 is above the median of 1 (87th percentile). Dated 166 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 5 · 87th percentile of 2,570 DeviceEstablishmentPulse records · 5.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 83 related FL DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentOsteomni Inc
RoleSpecification developer (outsources manufacturing)
Establishment typesDevelop Specifications But Do Not Manufacture At This Facility
LocationMiami, FL, US
New listings5
DevicesIntervertebral 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 codesODP, MAX, MQP, OVE, PLR
Device classesClass II
Medical specialtiesOrthopedic
Brand namesOMBC3211 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 listing2026-05-22
Latest new listing2026-05-22
FDA registration number3041915189
Registration expires2026-12-31
amount percentile87th of 2,570 (median 1, 5.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-05-22
  • Data refreshed: 2026-10-28
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Osteomni Inc and 84 Florida peers

  • Florida DeviceEstablishmentPulse records like this one: 84
  • Osteomni Inc's amount: 87th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Florida peer: $16,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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85 / 100 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.

What is the DeviceEstablishmentPulse record for Osteomni Inc in Miami, Florida?

Osteomni Inc (Miami, FL), a specification developer (outsources manufacturing), added 5 FDA device listings on 2026-05-22.

How does Osteomni Inc compare to other Florida DeviceEstablishmentPulse records?

Its amount of 5 sits in the upper half (87th percentile) of 2,570 records; the median is 1. It is 166 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.

Osteomni Inc vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Osteomni IncMiami, FL587th2026-05-22
Orthopediatrics, CorpWarsaw, IN587th2026-09-28
Wright Medical Technology, Inc.Arlington, TN587th2026-09-28
Alc Enterprises IncBrooklyn, NY483rd2026-10-18

Related records

DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Florida

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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.

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