BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A.

FDA Device Registration & Listing · Rohrmoser San Jose, CR · Registration 3027242374

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
3027242374
FEI Number
3027242374
Entity Name
BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A.
City/State/Country
Rohrmoser San Jose, CR
Establishment Address
Oficentro Don Hugo Local #1, 250 este del Centro Comercial Plaza Mayor, Rohrmoser San Jose 10109, CR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Biotec Biotecnologias de Centroamerica S.A. (Owner Number: 10087853)
Owner / Operator Contact Address
Oficentro Don Hugo Local #1, 250 este del Centro Comercial Plaza Mayor, Rohrmoser, CR-SJ 10109, CR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

CLAMP AIR SAFETY HEPA AND NON-HEPA FILTERS GAUGE, DEPTH FORCEPS MINI TIGHTROPE MICROSUTURE ANCHORS CAMERA, SURGICAL AND ACCESSORIES

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-20
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
HRX Arthroscope Orthopedic Class 2 888.1100 2023-04-20
HXD Clamp General, Plastic Surgery Class 1 878.4800 2025-07-24
HRX Arthroscope Orthopedic Class 2 888.1100 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-04-20
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2023-04-20
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-07-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-24
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2023-04-20
HRX Arthroscope Orthopedic Class 2 888.1100 2023-04-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-04-20
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-07-24
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-04-20
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-20
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2023-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
HTD Forceps General, Plastic Surgery Class 1 878.4800 2025-07-24
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-07-24
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-07-24
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-20
HXJ Staple Driver Orthopedic Class 1 888.4540 2023-04-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2025-07-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-20
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-24
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-24

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

Biotec Biotecnologias de Centroamerica 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
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-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 3027242374. Last updated year: 2026. Please use registration number 3027242374 when referencing this establishment in official correspondence.
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