BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS)

FDA Device Registration & Listing · Quito Pichincha, EC · Registration 3021336182

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021336182
FEI Number
3021336182
Entity Name
BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS)
City/State/Country
Quito Pichincha, EC
Establishment Address
Francisco Casanova and Portugal, Quito Pichincha 170504, EC
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Biocells Discoveries Internacional (Biocells) (Owner Number: 10083835)
Owner / Operator Contact Address
Francisco Casanova and Portugal, Quito, EC-P 170504, EC
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK070069
PMA Number
N/A

All Registered Proprietary Names

Medical device data system Orthopedic manual surgical instrument MENISCAL CINCH INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE CAMERA, SURGICAL AND ACCESSORIES Table And Attachments, Operating-Room Camera, Television, Surgical, Without Audio BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) BUR, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE Protector, skin pressure Accessories, arthroscopic Bit, Drill Apparatus, traction, non-powered Reamer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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 2021-12-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-07-16
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2021-12-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-07-16
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-07-16
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 2025-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-06
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
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
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
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-08-03
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2025-07-16
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2024-08-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-06
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-27
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2025-07-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-16
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2021-12-27
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2021-12-27
FWB Camera, Television, Surgical, Without Audio General, Plastic Surgery Class 1 878.4160 2024-08-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-07-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-01-18
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-12-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-12-08
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
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-11-16
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2021-12-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-08
HRX Arthroscope Orthopedic Class 2 888.1100 2023-12-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-11-16
FEM Accessories, Photographic, For Endoscope (Exclude Light Sources) Gastroenterology, Urology Class 1 876.1500 2023-05-31
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2021-12-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-06
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2024-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-16
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-07-16
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 2023-05-31
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2022-07-21
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2021-12-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-27
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-07-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-16
HTW Bit, Drill Orthopedic Class 1 888.4540 2021-12-27
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2021-12-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-06
HTO Reamer Orthopedic Class 1 888.4540 2023-05-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-06
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-08-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-01-18
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2022-11-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-11-16
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-07-16

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

Biocells Discoveries Internacional (Biocells)
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
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
K171060 Riverpoint Medical OrthoButton AL 2017-06-02
K231867 Paragon 28, Inc. Grappler Suture Anchor System 2023-08-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011 Depuy Orthopaedics, Inc. 1
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021336182. Last updated year: 2026. Please use registration number 3021336182 when referencing this establishment in official correspondence.
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