SPITREX ORTHOPEDICS SWITZERLAND SA

FDA Device Registration & Listing · Le Locle Neuchatel, CH · Registration 3011500362

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
3011500362
FEI Number
3011500362
Entity Name
SPITREX ORTHOPEDICS SWITZERLAND SA
City/State/Country
Le Locle Neuchatel, CH
Establishment Address
Girardet 29, Le Locle Neuchatel 2400, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SPITREX ORTHOPEDICS SWITZERLAND SA (Owner Number: 10047874)
Owner / Operator Contact Address
Girardet 29, Le Locle, CH-NE 2400, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ACE OPEN-BACK HALO RING ACE 3.5MM CORTICAL BONE SCREW ACE PROXIMAL HUMERAL NAIL SYSTEM - VERSANAIL DEPUY ACE TIMAX META PLATE ACE RECONSTRUCTIVE PLATE ACE/KYLE CAPTURED HIP SCREW ACE CORTICAL BONE SCREW ALPS Total Foot System - CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824 Tyber Medical Anatomical Plating System TM Plating System (Proximal Femur) SMALL FRAGMENT LOCKING PLATING SYSTEM TROCHANTERIC NAIL ALPS HANS SYSTEM-SMALL BONE LOCKING PLATING SYSTEM POLYAX LOCKED PLATING SYSTEM ALPS Screw, fixation, bone ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM -VERSANAIL ALPS Proximal Tibia Plating System ACE BROOKER BONE PLATING SYSTEM DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION ACE AIM TTC FUSION NAIL - CORTICAL SCREW DIST TIB MEDIAL LT 9H DIST TIB MEDIAL LT 15H LOCKING DIST TIB MEDIAL LT 6H LOCKING DIST TIB MEDIAL LT 12H LOCKING DIST TIB MEDIAL RT 6H DIST TIB MEDIAL RT 15H BIOMET INC LOCKING DIST TIB MEDIAL RT 12H DIST TIB MEDIAL RT 9H ACE BIO WIN TIBIAL NAILING SYSTEM CORTICAL LOCKING SCREWS ZINDRICK IM ROD -SCREW CORTICAL Tyber Medical Distal Radius Plating System LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM - CORT LOCK SCRW ACE CANCELLOUS BONE SCREW DEPUY ACE VERSANAIL TIBIAL NAIL THACKRAY TITANIUM MINI-PLATING SYSTEM - CORTICAL SCREW ALPS AIM SUPRACONDYLAR NAIL - SOLID END CAP ALPS Total Foot System -DEPUY FRACTURE AND FUSION PLATING SYSTEM ANATOMIC LOCKING PLATING SYSTEM ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTE - CANC LOCK SCRW DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL - ENDCAP IMPING DEPUY ACE TK2 HIP SCREW SYSTEM -LOCKING CORTICAL SCREW ACE CANCELLOUS BONE SCREW - VERSANAIL CORTICAL LOCKING SCREWS ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW ACE VERSANAIL ACE MULTIPLE PIN PLATE -BUTTRESS PLATE ACE SOLID CANCELLOUS BONE SCREW

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-22
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-11-25
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-11-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-11-25
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-11-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-01-04
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2022-11-10
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-11-10
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-09-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-11-10
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-01-03
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-01-03
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-01-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-11-10
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-10
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-11
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-01-03
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-01-03
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-07-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-07-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-07-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-11-11
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2023-01-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-11-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-11

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

SPITREX ORTHOPEDICS SWITZERLAND SA
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 3011500362. Last updated year: 2026. Please use registration number 3011500362 when referencing this establishment in official correspondence.
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