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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 11 of 82| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Black Belt Blunt Blade | 7324-50 | FDA UDI | Class II | Active |
| Osteotome | 7452-69 | FDA UDI | Class I | Active |
| Curette | 7418-82L | FDA UDI | Class I | Active |
| Black Belt Blunt Ti Blade | 7320-C-22-85 | FDA UDI | Class II | Active |
| Self-Retaining Retractor for Transverse Retractor Set | 7300-10 | FDA UDI | Class I | Active |
| Alif Lateral Blade Head | 7332-20 | FDA UDI | Class I | Active |
| Renal Vein Swivel Retractor | 9883-44R | FDA UDI | Class I | Active |
| Suction Tube | 7219-27 | FDA UDI | Class I | Active |
| OP Rongeur | 7377-43 | FDA UDI | Class I | Active |
| Forcep | 9230-07 | FDA UDI | Class I | Active |
| Cloward Hand Retractor | 7233-78 | FDA UDI | Class I | Active |
| IVD Rongeur | 7376-20S | FDA UDI | Class I | Active |
| Lumbar Micro Discectomy Specula Retractor | 7270-85 | FDA UDI | Class I | Active |
| Super-Slide Sacral Blade | 7329-442 | FDA UDI | Class II | Active |
| Super-Slide II Unilateral Head and T-Blade Assembly | 7329-64 | FDA UDI | Class II | Active |
| Comfort Plus Chisel | 7542-30 | FDA UDI | Class I | Active |
| Tower Attachment Set | 8800-552 | FDA UDI | Class I | Active |
| Shen Retractor | 8665-20 | FDA UDI | Class I | Active |
| Elevator | 7421-11 | FDA UDI | Class I | Active |
| Chisel | 7465-09 | FDA UDI | Class I | Active |
| Ejector Power Punch Rongeur | 7384-92 | FDA UDI | Class I | Active |
| Slim-Fit Curette | 7571-72 | FDA UDI | Class I | Active |
| Suction Tube | 7217-24 | FDA UDI | Class I | Active |
| OP Rongeur | 7375-62 | FDA UDI | Class I | Active |
| Osteotome | 7450-16 | FDA UDI | Class I | Active |
| Scissor | 9120-09 | FDA UDI | Class I | Active |
| Comfort Plus Instrument Case | 7520-30 | FDA UDI | Class I | Active |
| Viper Scoliosis Retractor | 7248-40 | FDA UDI | Class I | Active |
| U.S. Army Retractor | 7234-32 | FDA UDI | Class I | Active |
| Craig Pin Remover Set | 7790-00 | FDA UDI | Class I | Active |
| Blade Adjustor | 7332-84 | FDA UDI | Class I | Active |
| Vista Improved Extended Retractor System | 7319-02 | FDA UDI | Class I | Active |
| Koros-Scaglietti Osteotome Set | 7452-00 | FDA UDI | Class I | Active |
| OP Rongeur | 7376-94 | FDA UDI | Class I | Active |
| Elevator | 7230-40 | FDA UDI | Class I | Active |
| Caspar Micro Discectomy Blade | 7275-70 | FDA UDI | Class I | Active |
| Glover Bulldog | 9315-09 | FDA UDI | Class I | Active |
| Black Belt Two-Level Pronged Blade | 7320-F-27-100 | FDA UDI | Class II | Active |
| Curette | 7404-03 | FDA UDI | Class I | Active |
| CardioBay Aortic Retractor | 8980-76 | FDA UDI | Class I | Active |
| Richardson Retractor | 9900-93 | FDA UDI | Class I | Active |
| Instrument Tray | 7360-90 | FDA UDI | Class I | Active |
| Curette | 7566-17 | FDA UDI | Class I | Active |
| IVD Rongeur | 7378-40S | FDA UDI | Class I | Active |
| Slim-Fit Curette | 7571-80 | FDA UDI | Class I | Active |
| Round Bone Impactor | 7224-52 | FDA UDI | Class II | Active |
| Malleable Swivel Retractor | 9882-74 | FDA UDI | Class I | Active |
| Curette | 7793-15 | FDA UDI | Class I | Active |
| IMA Tower Blunt Rake Retractor | 8897-54B | FDA UDI | Class I | Active |
| Multi-Punch Rongeur | 7378-49 | FDA UDI | Class I | Active |
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