Gramercy Extremity Orthopedics, LLC. (manufacturer, Richardson, TX): 9 new FDA device listings, incl. countersink
Gramercy Extremity Orthopedics, LLC. (Richardson, Texas): 9 new FDA device listings, incl. countersink. Its amount of 9 is top-decile (92nd percentile of 2,570 records). Dated 133 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 9 · 92th percentile of 2,570 DeviceEstablishmentPulse records · 9.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 67 related TX DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 92th of 2,570 (median 1, 9.0x median) |
| Peer records CSV (68 TX records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-06-24
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (TX first): Sterigenics US LLC (contract sterilizer, Fort Worth, TX) · Sterigenics US LLC (contract sterilizer, Grand Prairie, TX) · Midwest Sterilization Corp. (contract sterilizer, Laredo, TX · Mlife Diagnostics LLC (contract manufacturer, Marshall, TX) · Inspiration Medical Technology, Inc. (repackager or relabele · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Gramercy Extremity Orthopedics, LLC. and 68 Texas peers
- Texas DeviceEstablishmentPulse records like this one: 68
- Gramercy Extremity Orthopedics, LLC.'s amount: 92nd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Texas peer: $13,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Gramercy Extremity Orthopedics, LLC. in Richardson, Texas?
Gramercy Extremity Orthopedics, LLC. (Richardson, TX), a manufacturer, added 9 FDA device listings on 2026-06-24.
How does Gramercy Extremity Orthopedics, LLC. compare to other Texas DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 9 is 9.0x the median of 1 across 2,570 records. It is 133 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Gramercy Extremity Orthopedics, LLC. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Gramercy Extremity Orthopedics, LLC. | Richardson, TX | 9 | 92nd | 2026-06-24 |
| Paragon 28 | Englewood, CO | 9 | 92nd | 2026-10-08 |
| Boston Scientific Corporation | Coventry, RI | 10 | 93rd | 2026-10-16 |
| Abyrx, Inc. | Stamford, CT | 7 | 90th | 2026-10-07 |
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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.