Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012329552

FEI Number

3012329552

Entity Name

ORTOSISTEMAS, S.A.

City/State/Country

Panama, PA

Establishment Address

Calle Elida Diez, Urbanizacion El Carmen. Bella Vista, Panama 238-0816, PA

Establishment Type(s)

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

Owner / Operator

Ortosistemas, S.A. (Owner Number: 10083460)

Owner / Operator Contact Address

Calle Elida Diez, Urbanizacion El Carmen. Bella Vista, Panama, PA-8 238-0816, PA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153218

PMA Number

N/A

All Registered Proprietary Names

Camera, Surgical And Accessories accessories, arthroscopic Arthrex Low Profile Screws instrument, manual, surgical, general use protector, skin pressure component, traction, non-invasive apparatus, traction, non-powered Arthrex Synergy Vision Endoscopic Imaging System Bit, Drill gauge, depth Table And Attachments, Operating-Room Orthopedic manual surgical instrument. Reamer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-11-22
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2025-07-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-07-24
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-11-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-22
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2023-08-04
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2023-08-04
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2021-11-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-11-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-11-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-06-10
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2022-06-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-11-22
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-11-22
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-07-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-11-22
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2022-06-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-07-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-07-24
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2025-07-24
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-07-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-11-15
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-12-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-12-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-11-15
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-11-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-11-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-11-15
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-04-02
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-07-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-07-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-18
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-12-18
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-11-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-11-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-11-15
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-11-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-22
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2022-06-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-05-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-11-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-11-15
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2021-11-22
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-11-15
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-11-15
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-11-22
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-11-22
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2022-07-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-04-02
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2024-04-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-11-15
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-11-15
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2022-06-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-04-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-04-02
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2021-11-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-11-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-07-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-22
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-05-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-11-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-05-23
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2023-12-18
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2021-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-11-22
HTO	Reamer	Orthopedic	Class 1	888.4540	2022-06-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-11-22

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

Ortosistemas, 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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07

Related Recall Records

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Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012329552. Last updated year: 2026. Please use registration number 3012329552 when referencing this establishment in official correspondence.