ORTHO PRECISION PRODUCTS

FDA Device Registration & Listing · Hawthorne, CA, US · Registration 3011053036

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
3011053036
FEI Number
3011053036
Entity Name
ORTHO PRECISION PRODUCTS
City/State/Country
Hawthorne, CA, US
Establishment Address
3201 W. El Segundo Blvd, Hawthorne, CA 90250, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Gamboa (Owner Number: 10047394)
Owner / Operator Contact Address
3201 W. El Segundo Blvd, Hawthorne, CA 90250, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Tiger Headless Cannulated Screw

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-08-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-08-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-08-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-08-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-06-13

Official Correspondent

Mark Gamboa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gamboa
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
K040336 Synthes (Usa) SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 2004-04-12
K083648 Efratgo, Ltd. HI Tech Bio-Surgical GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL 2009-05-14
K192312 Zimmer GmbH Zimmer Natural Nail System Cephalomedullary Nails 2019-10-11
K002057 Biomet Orthopedics, Inc. BROOKER TIBIA NAILS 2000-10-04
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

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 3011053036. Last updated year: 2026. Please use registration number 3011053036 when referencing this establishment in official correspondence.
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