# Surgical Instrument Manufacturers, LLC (contract manufacturer, Fenton, MO): 13 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Surgical Instrument Manufacturers, LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Fenton, MO, US |
| New listings | 13 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Sacroiliac Joint Fixation; Spinal Vertebral Body Replacement Device; Intervertebral Fusion Device With Integrated Fixation, Cervical; Intervertebral Fusion Device With Bone Graft, Cervical; Thoracolumbosacral Pedicle Screw System; Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation; Appliance, Fixation, Spinal Interlaminal |
| Product codes | MAX, OUR, MQP, OVE, ODP, NKB, MNI, MNH, KWP |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Harrier-SA Lumbar Interbody System; ChoiceSpine TigerShark M, Modular Interbody System; Veo; Triton Sacroiliac Joint Fixation System; ORIA NATURA SPACER; ChoiceSpine Blackhawk Ti Cervical Spacer System; ChoiceSpine Stealth Cervical Spacer System; THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS |
| First new listing | 2026-09-25 |
| Latest new listing | 2026-09-25 |
| FDA registration number | 1935627 |
| 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.
- Listed in the last 45 days.

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.