INNOMED, S.A. DE C.V.

FDA Device Registration & Listing · San Salvador, SV · Registration 3006498370

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
3006498370
FEI Number
3006498370
Entity Name
INNOMED, S.A. DE C.V.
City/State/Country
San Salvador, SV
Establishment Address
29 Avenida Norte #1127, col. Buenos Aires, entre calle Gabriela Mistral y 21 calle poniente, San Salvador 01101, SV
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Innomed, S.A. DE C.V. (Owner Number: 10083335)
Owner / Operator Contact Address
29 Avenida Norte #1127, col. Buenos Aires, entre calle Gabriela Mistral y 21 calle poniente, San Salvador, SV-SS 01101, SV
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Low Profile Screws Instrument, Manual, Surgical, General Use Dressing, Wound, Drug INTERFERENCE SCREW Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Reamer Orthopedic Manual Surgical Instrument MENISCAL CINCH Electrodes and accessories System, Digital Image Communications, Radiological ARTHOERESIS IMPLANT Blade, Saw, General & Plastic Surgery, Surgical Medical Device Data System Arthroscope CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY SMALL FRAGMENT PLATES AND SCREWS Syringe, Piston LOW PROFILE SCREWS Table and Attachments, Operating-Room SONY VIDEO PRINTERS, UP SERIES FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-12
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2021-11-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-24
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-07-24
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-07-24
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-07-24
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-11-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-11-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-06-09
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-06-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-08
FRO Dressing, Wound, Drug Unknown Class U N/A 2021-11-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-23
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-05-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-06-09
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-11-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-09
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-25
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-05-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-05-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-06-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-05-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-27
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2021-11-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-06-09
HTO Reamer Orthopedic Class 1 888.4540 2022-11-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-05-25
HRX Arthroscope Orthopedic Class 2 888.1100 2023-05-25
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2021-11-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-11-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-11-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-05-25
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-01-10
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-01-10
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2025-01-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-11-11
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2023-12-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-11-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-01-18
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-01-18
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-10-16
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-05-25
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-01-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-05-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-01-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-05-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-11-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-05-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-01-10
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2021-11-12
OUG Medical Device Data System General Hospital Class 1 880.6310 2022-06-09
HRX Arthroscope Orthopedic Class 2 888.1100 2021-11-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-11-11
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-11
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2022-07-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-21
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-05-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2021-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-11-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-11-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-11-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-11
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2025-01-10
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-07-24
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2023-12-08
HRX Arthroscope Orthopedic Class 2 888.1100 2022-06-09
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-06-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-09
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2021-11-12

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

Innomed, S.A. DE C.V.
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 3006498370. Last updated year: 2026. Please use registration number 3006498370 when referencing this establishment in official correspondence.
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