FDA Registration
Active
🇺🇸 United States
Arthrex California Technology, Incorporated
Reg #: 3006990600
·
FEI: 3006990600
·
Expires 2026
Products
16
Proprietary Names
8
Establishment Types
4
Classifications
16
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Registration Details
- Registration Name
- Arthrex California Technology, Incorporated
- Registration Number
- 3006990600
- FEI Number
- 3006990600
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 460 Ward Dr
- City
- Santa Barbara
- State
- CA
- ZIP
- 93111
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252314
Owner / Operator
- Firm Name
- ARTHREX, INC.
- Operator Number
- 1220287
- Address
- 1370 CREEKSIDE BLVD., --
- City
- Naples
- State
- FL
- Postal Code
- 34108
- Country
- US
- Correspondent
- Barry Dietz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Special Lens, For Endoscope | FEI | Class 1 | Gastroenterology, Urology | No | 2017-01-25 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-11-19 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2025-11-19 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 1996-08-07 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-08-23 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-05-01 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2007-08-23 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-12-31 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2024-05-23 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2025-11-19 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2025-11-19 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-09-12 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Camera, Television, Surgical, Without Audio | FWB | Class 1 | General, Plastic Surgery | No | 2024-07-25 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-12-13 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2017-01-25 |
Proprietary Names
Instrument, Special Lens, For Endoscope
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
ORTHOPEDIC MANUAL INSTRUMENTS
VARIOUS INSTRUMENTS
SHAVER SYSTEM
Instrument, manual, surgical, general use
Camera, Television, Surgical, Without Audio
Camera Heads
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Develop Specifications But Do Not Manufacture At This Facility