# TOMZ Corporation (contract manufacturer, Berlin, CT): 36 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | TOMZ Corporation |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Berlin, CT, US |
| New listings | 36 |
| Devices | Intervertebral Fusion Device With Bone Graft, Cervical; Appliance, Fixation, Spinal Intervertebral Body; Appliance, Fixation, Spinal Interlaminal; Thoracolumbosacral Pedicle Screw System; Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Product codes | ODP, KWQ, KWP, NKB, MNI, MNH, OSH, PHM, MAX, OVD, NKG, OUR, PML |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| First new listing | 2026-09-09 |
| Latest new listing | 2026-09-09 |
| FDA registration number | 1224360 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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: 2026-11-04T21:52:36.524Z.
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.