Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021393544

FEI Number

3021393544

Entity Name

BIOGENOMICS S.A.C. - BIOCELLS SURGICAL

City/State/Country

Lima, PE

Establishment Address

AV. GUARDIA CIVIL 1321, OFFICE 1303, Lima 15036, PE

Establishment Type(s)

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

Owner / Operator

Biogenomics S.A.C. - Biocells Surgical (Owner Number: 10084035)

Owner / Operator Contact Address

AV. GUARDIA CIVIL 1321, OFFICE 1303, Lima, PE-LMA 15036, PE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082810

PMA Number

N/A

All Registered Proprietary Names

CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO Instrument, Special Lens, For Endoscope Blade, Saw, General & Plastic Surgery, Surgical Camera, Surgical And Accessories INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT accessories, arthroscopic Protector, Skin Pressure medical device data system Apparatus, traction, non-powered Accessories, Photographic, For Endoscope (Exclude Light Sources) bur, surgical, general & plastic surgery Orthopedic manual surgical instrument. Table And Attachments, Operating-Room COMPONENT, TRACTION, NON-INVASIVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2024-08-27
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-01-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-01-12
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2022-11-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-01-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-07-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-07-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-01-12
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2022-01-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-07-16
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-01-12
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-02-06
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2022-01-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-01-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-07-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-07-21
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2022-01-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-04-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-22
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2023-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-07-16
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-07-16
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2022-06-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2022-01-11
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2022-01-12
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2023-12-08
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2022-11-14
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2024-08-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-08-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-01-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-01-12
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-06-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-01-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-01-12
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2022-01-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-01-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-01-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-07-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-07-16
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-01-12
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2023-12-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-01-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-01-12
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-06
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2025-07-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-01-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-01-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-01-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-07-16
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-01-12
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2022-01-12
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2022-01-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-01-12

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

Biogenomics S.A.C. - Biocells Surgical

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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3030548301	KRYPTONITE SOLUTIONS	Mumbai Maharashtra, IN
3014004349	Arthrex Singapore Pte Ltd.	Singapore Central Singapore, SG
3016727307	VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY	Hanoi Ha Noi, VN
1220246	ARTHREX, INC.	Naples, FL, US
3031238646	Arthrex Medical Device (Shanghai) Co. Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021393544. Last updated year: 2026. Please use registration number 3021393544 when referencing this establishment in official correspondence.