# Gramercy Extremity Orthopedics, LLC. (manufacturer, Richardson, TX): 9 new FDA device listings, incl. countersink

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Gramercy Extremity Orthopedics, LLC. |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Richardson, TX, US |
| New listings | 9 |
| Devices | Countersink; Tap, Bone; Bender; Orthopedic Manual Surgical Instrument; Gauge, Depth; Bit, Drill; Template; Reamer; Staple Driver |
| Product codes | HWW, HWX, HXW, LXH, HTJ, HTW, HWT, HTO, HXJ |
| Device classes | Class I |
| Medical specialties | Orthopedic |
| Brand names | Countersink - Cannulated; Drill Tap; Plate Bender; Wire Guide; EPS Plate Non-Locking Drill Guide; AO Handle - Cannulated; EPS Plate Locking Drill Guide; Hexalobe Driver Tip - Cannulated |
| First new listing | 2026-06-24 |
| Latest new listing | 2026-06-24 |
| FDA registration number | 3012478585 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- 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.