ORTHO-MED, INC.

FDA Device Registration & Listing · Tigard, OR, US · Registration 3019455

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
3019455
FEI Number
3019455
Entity Name
ORTHO-MED, INC.
City/State/Country
Tigard, OR, US
Establishment Address
14875 SW 72nd Ave, Tigard, OR 97224, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
ORTHO-MED, INC. (Owner Number: 3019455)
Owner / Operator Contact Address
14875 SW 72nd Ave, --, Tigard, OR 97224, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC Ortho-Med Inc ORTHOMED INC ORTHOMED INC ORTHOMED INC Orthomed, Inc. Orthomed, Inc. ORTHOMED INC ORTHOMED INC ORTHOMED INC Orthomed Ortho-Med Inc ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC Ortho-Med Inc ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC Ortho-Med Inc ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC Orthomed Rongeurs Ortho-Med Inc ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC ORTHOMED INC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2019-12-18
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2019-12-18
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-12-18
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2019-12-18
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2022-08-31
GWY Pinwheel Neurology Class 1 882.1750 2022-08-31
HWA Impactor Orthopedic Class 1 888.4540 2019-12-18
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2026-06-17
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2019-12-18
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-12-18
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2022-08-31
HTO Reamer Orthopedic Class 1 888.4540 2024-12-16
HXD Clamp General, Plastic Surgery Class 1 878.4800 2024-02-26
GAD Retractor General, Plastic Surgery Class 1 878.4800 2019-12-18
HXL Mallet General, Plastic Surgery Class 1 878.4800 2019-12-18
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2019-12-18
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2008-05-01
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2026-04-16
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2019-12-18
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2019-12-18
HTF Curette General, Plastic Surgery Class 1 878.4800 2019-12-18
LRZ Screwdriver, Surgical General, Plastic Surgery Class 1 878.4800 2019-12-18
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2019-12-18
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2019-12-18
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2019-12-18
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2019-12-18
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2019-12-18
FSH Tray, Surgical, Needle General, Plastic Surgery Class 1 878.4800 2026-06-16
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2019-12-18
EJY Pliers, Operative Dental Class 1 872.4565 2019-12-18
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2019-12-18
HXG Tamp Orthopedic Class 1 888.4540 2019-12-18
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2019-12-18
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2026-06-16
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-12-18
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2019-12-18
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2022-08-31
HWK Trephine Orthopedic Class 1 888.4540 2019-12-18
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2019-12-18
HTX Rongeur Orthopedic Class 1 888.4540 2018-08-02
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2026-06-16
HWW Countersink Orthopedic Class 1 888.4540 2019-12-18
HWB Extractor Orthopedic Class 1 888.4540 2022-08-31
HTR Rasp General, Plastic Surgery Class 1 878.4800 2019-12-18
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-12-18
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-12-18
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2019-12-18
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2022-08-31
HTE Elevator General, Plastic Surgery Class 1 878.4800 2019-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHO-MED, 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
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06
K894785 Fdt Precision Machine Co., Inc. SURGICAL CHISEL/OSTEOTOME 1989-08-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2008 N/A 1
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019455. Last updated year: 2026. Please use registration number 3019455 when referencing this establishment in official correspondence.
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