# Ortho Max Inc (other, Palm City, FL): 14 new FDA device listings, incl. orthopedic manual surgical instrument

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Ortho Max Inc |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Palm City, FL, US |
| New listings | 14 |
| Devices | Orthopedic Manual Surgical Instrument; Plate, Fixation, Bone; Screw, Fixation, Bone; Fastener, Fixation, Nondegradable, Soft Tissue |
| Product codes | LXH, HRS, HWC, MBI |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic |
| Brand names | ACL Reamer - 8mm; ACL Reamer - 12mm; MINI HOHMANN RETR. 6 1/2" - 6mm; ACL Reamer - 6mm; MINI HOHMANN RETR. 6 1/2" - 8mm; ACL Reamer - 7mm; BONE REDUCTION FORCEPS - 5"; TERMITE FORCEPS - 3 1/2" |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-08-26 |
| FDA registration number | 3013843230 |
| 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.