Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012883081

FEI Number

3012883081

Entity Name

CROSMED S.A.

City/State/Country

Buenos Aires, AR

Establishment Address

Aguirre 545, Buenos Aires 1414, AR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Crosmed S.A. (Owner Number: 10085790)

Owner / Operator Contact Address

Aguirre 545, Buenos Aires, AR-B 1414, AR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200341

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-04
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2024-04-04
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-04-04
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-04-04
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-08-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-08-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-04-04
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-04-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-04-04
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2022-08-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-08-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-08-03
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-08-09
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-04-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-03
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2024-08-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-08-09
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2024-08-27
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2022-08-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-08-03
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-08-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-04-04
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2023-12-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-04-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-03
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2022-08-09
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-04-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-01-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-08-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-08-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-08-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-08-27
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2022-08-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-08-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-04-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-04-03
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2022-08-09
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2023-08-03
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-04-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-04-03
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2024-08-27
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-08-09
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2024-08-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-02-06
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-02-06
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-08-09
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2024-02-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-01-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-08-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-08-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-08-27
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2022-08-09
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2025-01-10
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-10
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2022-08-09
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-04-03
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

Barry Dietz Business: Arthrex Inc Email: Regulatory_Affairs@Arthrex.com Phone: (800) 9337001

Related Public Records

Same Entity

Crosmed S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012883081. Last updated year: 2026. Please use registration number 3012883081 when referencing this establishment in official correspondence.