# Engineered Medical Systems, LLC (contract manufacturer, Bartlett, TN): 29 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Engineered Medical Systems, LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Bartlett, TN, US |
| New listings | 29 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Bone Graft, Thoracic; Orthopedic Stereotaxic Instrument; Spinal Vertebral Body Replacement Device; Spinal Vertebral Body Replacement Device - Cervical; Intervertebral Fusion Device With Bone Graft, Cervical; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Product codes | MAX, PHM, OLO, MQP, PLR, ODP, NKB, KWP, KWQ, OVD, NKG |
| Device classes | Class II |
| Medical specialties | Orthopedic, Neurology |
| Brand names | Invictus OsseoScrew |
| First new listing | 2026-07-17 |
| Latest new listing | 2026-09-03 |
| FDA registration number | 3009973336 |
| 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.