Transmedic Philippines Inc.

FDA Device Registration & Listing · Makati City Manila, PH · Registration 3020899789

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
3020899789
FEI Number
3020899789
Entity Name
Transmedic Philippines Inc.
City/State/Country
Makati City Manila, PH
Establishment Address
9F Petron Mega Plaza, #358 Sen. Gil, Puyat Avenue, Brgy., Bel-Air, Makati City Manila 1209, PH
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Transmedic Philippines Inc. (Owner Number: 10084837)
Owner / Operator Contact Address
9F Petron Mega Plaza, #358 Sen. Gil, Puyat Avenue, Brgy., Bel-Air, Makati City, PH-MAN 1209, PH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K090107
PMA Number
N/A

All Registered Proprietary Names

Bedding, Disposable, Medical Table And Attachments, Operating-Room Rongeur FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE PUNCH, SURGICAL Instrument, Manual, Surgical, General Use Apparatus, Traction, Non-Powered Component, Traction, Non-Invasive MENISCAL CINCH Accessories, Arthroscopic PROBE Orthopedic Manual Surgical Instrument MALLET, SURGICAL, GENERAL & PLASTIC SURGERY MINI TIGHTROPE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2023-08-04
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2022-06-02
HRX Arthroscope Orthopedic Class 2 888.1100 2022-04-06
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-04-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-06
HTX Rongeur Orthopedic Class 1 888.4540 2023-08-04
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-04-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-07-24
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-07-24
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2023-08-04
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2023-12-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-08-04
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-04-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-07-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-07-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-06
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-04-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-06-10
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-06
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2022-06-02
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2022-06-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-06
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2023-12-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-04-06
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2022-06-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-06
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-04-06
HXB Probe Orthopedic Class 1 888.4540 2023-12-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-11-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-15
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-11-15
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
HRX Arthroscope Orthopedic Class 2 888.1100 2022-04-06
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2022-06-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-02
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-06-02
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-12-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-04-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-06
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-04-06

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

Transmedic Philippines Inc.
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
K812396 Northwest Surgical Concepts, Inc. ARTHRO-PREP REST 1981-11-20
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
K153770 In2bones Sas OS2(R)-VP Varisation Staple 2016-03-21
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0008-2023 Synthes (USA) Products LLC 2
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020899789. Last updated year: 2026. Please use registration number 3020899789 when referencing this establishment in official correspondence.
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