# Guardian Medical USA, Inc (contract manufacturer, Swanton, OH): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Guardian Medical USA, Inc |
| Owner / operator | Guardian Medical USA, LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Swanton, OH, US |
| New listings | 4 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Appliance, Fixation, Spinal Interlaminal; Posterior Cervical Screw System; Sacroiliac Joint Fixation |
| Product codes | MAX, KWP, NKG, OUR |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| First new listing | 2026-05-29 |
| Latest new listing | 2026-06-24 |
| FDA registration number | 3016261131 |
| 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.