# Fusionx Medtech Inc. (repackager or relabeler, Whittier, CA): 22 new FDA device listings, incl. instrument, manual, surgical, general use

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Fusionx Medtech Inc. |
| Owner / operator | FusionX MedTech Inc. |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Whittier, CA, US |
| New listings | 22 |
| Devices | Instrument, Manual, Surgical, General Use; Intervertebral Fusion Device With Bone Graft, Lumbar; Tape, Measuring, Rulers And Calipers; Guide, Needle, Surgical; Retractor; Orthopedic Manual Surgical Instrument; Pusher, Socket; Bender; Impactor; Instrument, Compression |
| Product codes | MDM, MAX, FTY, GDF, GAD, LXH, HXO, HXW, HWA, HWN, HYA, HTO, FSM, HWJ, LXK |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic |
| Brand names | Expansion Sleeve (?16) / Expansion Sleeve (?20.7); Persuader Sleeve; Free Arm; Dilator 6/Dilator 13/Dilator 14.5/Dilator 16.2/Outer Tube/Inner Tube/; Expansion Sleeve (?5) / Expansion Sleeve (?10.5) /; Expandable Lumbar Fusion Cage (Type I /Type II ); Test Rod/Trial 4/Trial 5/Trial 6/Trial 7/Trial 8; Trial (12X45)/Trial (12X50)/Trial (12X55) |
| First new listing | 2026-06-16 |
| Latest new listing | 2026-07-28 |
| FDA registration number | 3047889355 |
| Registration expires | 2026-12-31 |

## Why this score
- 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: 2026-10-28T20:51:27.468Z.
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.