FDA Registration
Active
🇦🇷 Argentina
CROSMED S.A.
Reg #: 3012883081
·
FEI: 3012883081
·
Expires 2026
Products
39
Proprietary Names
29
Establishment Types
1
Classifications
39
Registration Details
- Registration Name
- CROSMED S.A.
- Registration Number
- 3012883081
- FEI Number
- 3012883081
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Aguirre 545
- City
- Buenos Aires
- Country
- AR
Regulatory Submissions
- 510(k) Number
- K232755
Owner / Operator
- Firm Name
- Crosmed S.A.
- Operator Number
- 10085790
- Address
- Aguirre 545
- City
- Buenos Aires
- State
- AR-B
- Postal Code
- 1414
- Country
- AR
US Agent
- Business Name
- Arthrex Inc
- Contact Name
- Barry Dietz
- Address
- 1370 Creekside Blvd
- City
- Naples
- State
- FL
- ZIP
- 34108
- Country
- US
- [email protected]
- Phone
- 800 9337001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-04-04 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-04-04 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2024-04-04 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-04-04 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-08-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-08-09 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2022-08-09 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-08-03 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-08-03 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2022-08-09 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2024-04-03 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2024-08-27 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2022-08-09 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2024-08-27 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2022-08-09 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-08-09 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-12-08 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2022-08-09 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-01-10 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2022-08-09 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-08-09 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2023-08-03 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2024-04-03 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2024-08-27 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2022-08-09 |
| Instrument, Special Lens, For Endoscope | FEI | Class 1 | Gastroenterology, Urology | No | 2024-08-27 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2022-08-09 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2024-02-12 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2022-08-09 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2025-01-10 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-01-10 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2022-08-09 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-02-12 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2022-08-09 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2023-12-08 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2022-08-09 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2022-08-09 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2022-08-09 |
Proprietary Names
Orthopedic Manual Surgical Instrument
Apparatus, Traction, Non-Powered
MALLET, SURGICAL, GENERAL & PLASTIC SURGERY
MODIFICATION TO: ARTHREX INTERFERENCE SCREW
Platelet And Plasma Separator For Bone Graft Handling
Instrument, Manual, Surgical, General Use
40 L HIGH FLOW INSUFFLATOR F108
Bur, Surgical, General & Plastic Surgery
Bit, Drill
Camera, Surgical And Accessories
ARTHREX SWIVELOCK ANCHORS
Protector, Skin Pressure
Medical Device Data System
Gauge, Depth
Endoscope and accessories
Bedding, Disposable, Medical
Endoscope and accessories.
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Blade, Saw, General & Plastic Surgery, Surgical
Component, Traction, Non-Invasive
Table And Attachments, Operating-Room
Arthrex Thrombinator System
Probe
Punch, Surgical
Rongeur
ARTHREX BIO-PIN
ARTHREX INTERFERENCE SCREW
Reamer
Accessories, Arthroscopic
Establishment Types
Export Device to the United States But Perform No Other Operation on Device