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Sign in to claim this brandKoros USA, Inc.
US
Last updated May 23, 2026
What Koros USA, Inc. makes
Koros USA, Inc. manufactures reusable surgical retractors and rongeurs for orthopaedic, spinal, craniofacial, and ophthalmic procedures, including adjustable side-loading blades, self-retaining retractors, and bone curettes. Their portfolio also includes specialty tools like rib/sternum retractors, neonate valve retractors, and wire cutters, designed for precise tissue manipulation and bone removal. Instrument cases and elevators are included to support procedural workflows.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Koros USA, Inc. is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Koros USA, Inc. manufacture?
Koros USA, Inc. specializes in reusable surgical instruments primarily used in orthopaedic, spinal, craniofacial, and ophthalmic procedures. Their portfolio includes surgical retractors (such as adjustable side-loading blades and self-retaining retractors), rongeurs (for bone removal), bone curettes, rib/sternum retractors, neonate valve retractors, wire cutters, and elevators. These tools are designed to assist surgeons in precise tissue manipulation and bone resection during surgical interventions.
Where is Koros USA, Inc. based, and what does that mean for their regulatory standing?
Koros USA, Inc. is headquartered in the United States. This means their devices are subject to U.S. regulatory oversight, including requirements like listing in the FDA’s Unique Device Identifier (UDI) database. The company’s devices fall under FDA classifications of Class I and Class II, which determine the regulatory pathway for authorization but do not imply approval of the company itself.
Which regulatory registries or databases list Koros USA, Inc.’s devices?
Koros USA, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify device details like model names, manufacturers, and regulatory classifications. Listing in the UDI database is a requirement for devices marketed in the U.S., not an endorsement of the company.
How are Koros USA, Inc.’s devices classified by the FDA, and why does this matter?
Koros USA, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls (e.g., good manufacturing practices), while Class II involves additional performance standards or special controls. This classification determines the regulatory pathway for authorization but does not reflect the company’s overall approval status—only individual devices undergo this process.
What kinds of surgical procedures are Koros USA, Inc.’s retractors and rongeurs designed for?
Koros USA, Inc.’s retractors and rongeurs are engineered for specialized surgical fields like orthopaedics (e.g., joint or limb procedures), spinal surgery (e.g., spinal rongeurs for bone removal), craniofacial surgery (e.g., reusable craniofacial rongeurs), and ophthalmology (e.g., reusable bone curettes). Their adjustable and self-retaining designs help surgeons maintain clear access to surgical sites while minimizing tissue trauma during procedures like spinal fusions, rib resections, or craniotomies.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (4055)
Page 20 of 82| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Black Belt Extra Deep Pronged Ti Blade | 7322-90T | FDA UDI | Class II | Active |
| Curette | 7418-46L | FDA UDI | Class I | Active |
| Comfort Plus Mallet | 7534-20 | FDA UDI | Class I | Active |
| Black Belt Two-Level Pronged Ti Blade | 7326-40T | FDA UDI | Class II | Active |
| Curette | 7418-86L | FDA UDI | Class I | Active |
| Mini-Access Valve Retractor Set | 8798-00 | FDA UDI | Class I | Active |
| Kelly Swivel Retractor | 9883-28R | FDA UDI | Class I | Active |
| Hand Retractor | 7740-61 | FDA UDI | Class I | Active |
| Slim-Fit Curette | 7570-70 | FDA UDI | Class I | Active |
| Forcep | 9960-40 | FDA UDI | Class I | Active |
| Scissor | 9150-90 | FDA UDI | Class I | Active |
| AVR S-S Tower Attachment Set | 8950-75 | FDA UDI | Class I | Active |
| Universal Tower Arm Unit Right | 8780-15 | FDA UDI | Class I | Active |
| Comfort Plus Curette | 7564-07 | FDA UDI | Class I | Active |
| Curette | 7435-01 | FDA UDI | Class I | Active |
| Maroon Style Narrow Pronged Blade | 7325-16 | FDA UDI | Class II | Active |
| Black Belt Excel Pro Retractor Frame- Left Titanium | 7320-20PT | FDA UDI | Class II | Active |
| Curette | 7416-06L | FDA UDI | Class I | Active |
| Forcep | 7042-75T | FDA UDI | Class II | Active |
| Scissor | 9120-10 | FDA UDI | Class I | Active |
| Caspar TI Blade | 7316-76T | FDA UDI | Class I | Active |
| Black Belt Two-Level Pronged Blade | 7320-G-27-100 | FDA UDI | Class II | Active |
| Pro Scoville Hook | 9918-30 | FDA UDI | Class I | Active |
| Bone Graft Cutter | 7354-10 | FDA UDI | Class I | Active |
| Husky Plus Osteotome | 7575-30 | FDA UDI | Class I | Active |
| Foramenotomy Rongeur | 7391-39 | FDA UDI | Class I | Active |
| IMA Super-Slide Retractor Set | 8920-00 | FDA UDI | Class I | Active |
| Curette | 7415-06L | FDA UDI | Class I | Active |
| AVR Super-Slide Retractor Frame | 8950-10 | FDA UDI | Class I | Active |
| Kerrison Rongeur | 7380-78 | FDA UDI | Class I | Active |
| IMA Support Tower | 8920-30 | FDA UDI | Class I | Active |
| DA Anterior Rongeur | 7353-12 | FDA UDI | Class I | Active |
| Weitlaner Retractor | 7242-21 | FDA UDI | Class I | Active |
| Forcep | 7798-80 | FDA UDI | Class I | Active |
| MIS Foramenotomy Rongeur | 7376-62 | FDA UDI | Class I | Active |
| Pituitary Rongeur | 7364-40 | FDA UDI | Class I | Active |
| Needle Holder | 8109-23 | FDA UDI | Class I | Active |
| Curette | 7417-01L | FDA UDI | Class I | Active |
| Spinal Pro Rongeur | 7394-50 | FDA UDI | Class I | Active |
| Curette | 7391-92F | FDA UDI | Class I | Active |
| Black Belt Pronged Blade | 7322-34 | FDA UDI | Class II | Active |
| Super Slide Titanium 1" Wide Blade Radiolucent Retractor Set | 7329-200 | FDA UDI | Class II | Active |
| Suture Boot | 8800-572 | FDA UDI | Class I | Active |
| Weitlaner Retractor | 7242-05 | FDA UDI | Class I | Active |
| IVD Rongeur | 7379-20 | FDA UDI | Class I | Active |
| Black Belt Two-Level Pronged Ti Blade | 7320-E-27-65 | FDA UDI | Class II | Active |
| Suction Cannula | 8200-42 | FDA UDI | Class I | Active |
| Husky Plus Osteotome | 7575-20 | FDA UDI | Class I | Active |
| Black Belt Sterilizing Instrument Case 1.5 x 11 x 13 | 7319-90T | FDA UDI | Class I | Active |
| Richardson Retractor | 9900-91 | FDA UDI | Class I | Active |
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