PURACON GMBH

FDA Device Registration & Listing · Rosenheim Bavaria, DE · Registration 3004638532

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
3004638532
FEI Number
3004638532
Entity Name
PURACON GMBH
City/State/Country
Rosenheim Bavaria, DE
Establishment Address
Isarstrasse 1, Rosenheim Bavaria D-83026, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
puracon GmbH (Owner Number: 10028435)
Owner / Operator Contact Address
Isarstrasse 1, Rosenheim, DE-BY D-83026, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Clamps Flower Toe Cannulated and Solid Flex-ThreadTM Distal Fibula Intramedullary Nail System 88424, 8426, 8428, 8522, 8524, 8525, 8526, 8527, 8528, 8529, 853 BEE HA Cage cervical XX x YYmm ZZ POYA 3.5mm Medial Proximal Tibia System CASPIAN® Spinal System DENALI® MI Spinal System, DENALI® Spinal System, MESA® Small Stature Spinal System, MESA® Spinal MESA® Small Stature Spinal System Mohave Expandable Interbody System Cortical Screws TRIFT 3.5mm 1/3 Tubular Plates NGM WAVE Cage XX x Yymm ZZ CAPRI™ Corpectomy Cage System EVEREST® Spinal System CAPRI™ Corpectomy Cage System, EVEREST® Spinal System Orthopedic manual surgical instrument CASPIAN® Spinal System Calcaneus Plates MESA® Spinal System MESA® Small Stature Spinal System MESA® Small Stature Spinal System SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Right SALGINA 2.5mm Dorsal Distal Radius Plate, 6 Hole, Right LEPORELLO 3.5mm Olecranon Plate 7 Hole, Left SALGINA 2.5mm Wrist Spanning Plate SALGINA 2.5mm Volar Distal Radius Plate, Distal Narrow, 3 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Distal Narrow, 3 Hole, Left CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 15 Hole, Left SALGINA 2.5mm Volar Distal Radius Plate, Distal Wide, 3 Hole, Left CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 15 Hole, Right SALGINA 2.5mm Dorsal Distal Radius Plate, 6 Hole, Left SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Left LEPORELLO 3.5mm Olecranon Plate 7 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Distal Wide, 3 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Left Apex Femoral Nail System LORRAINE 2.5/3.5mm Distal Humerus System BEE PLIF Cage XX x YYmm ZZ EVEREST® Spinal System Cannulated screw Bone Screw Set, Ext. CASPIAN® Spinal System EVEREST® Spinal System Mediant Anterior Cervical Plating System MIS Z-Pedicle Screw System Mohave Expandable Interbody System SITTER 3.5mm Versatile System Depth Gauges Drill Guides BRUSIO Trauma Toolbox System TAMINA 3.5mm Proximal Humerus System neoWave C Cervical System Screw Racks MESA® Small Stature Spinal System neoWave C Cervical System Ti3D Cervical System neoWave LS Lumbar System MESA® Small Stature Spinal System Dental Bur IMPLANT, ENDOSSEOUS, ROOT-FORM Distal tibial A-Plate Straight Fibular Plate Anterior Lateral Distal Tibial Plate Medial Distal Tibial Plate Locking Fibular Plate ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Apex Nailing System Sterile Guidewire LEPORELLO 3.5mm Olecranon Plates Cortical screws DALVAZZA 2.5mm Distal Ulna Plate TAMINA 3.5mm Proximal Humerus Plates SALGINA 2.5mm Volar Distal Radius Plates CASCELLA 3.5mm Superior Clavicle Plates POYA 3.5mm Lateral Proximal Tibia Plates Variable Angle Locking Screws

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-01-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-01-10
HXW Bender Orthopedic Class 1 888.4540 2020-09-23
HXD Clamp General, Plastic Surgery Class 1 878.4800 2022-10-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-22
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2015-12-18
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-04-21
EJH Alloy, Metal, Base Dental Class 2 872.3710 2023-07-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-12-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-18
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2014-11-18
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-04-27
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-12-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-12-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-12-18
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2018-12-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-12-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-10-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-03-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-03-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-03-21
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2023-03-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-03-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-10-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-03-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-03-21
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2023-03-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-03-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-03-21
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-09-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-09-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-12-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-14
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2020-08-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-18
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2018-12-18
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2023-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-02-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-02-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2020-01-16
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2020-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2020-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-01-16
IQP Rotator, Transverse Physical Medicine Class 1 890.3025 2026-04-24
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2023-03-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-03-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-03-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-03-21
GAG Stapler, Surgical General Hospital Class 2 878.4740 2020-01-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-03-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-03-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-01-15
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-01-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-06-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-10-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-12-18
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2018-12-18
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-12-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-01
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2023-03-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-03-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-03-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-03-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-09-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-09-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-12-18
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2018-12-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-12-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-09-01
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-09-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-09-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-03-21
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-12-18
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2026-04-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-12-29
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-01-11
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2022-10-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-09-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-09-23
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-10-20
HTO Reamer Orthopedic Class 1 888.4540 2015-12-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-01-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-01-09
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2014-11-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-12-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-12-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-12-06
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-12-11
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-10-20
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2023-03-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-03-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-03-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-03-21
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2016-02-16
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2016-02-16
LOD Bone Cement Orthopedic Class 2 888.3027 2016-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-12-21
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-12-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-12-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-01-04
HXX Screwdriver Orthopedic Class 1 888.4540 2015-12-18
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2020-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-03-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-03-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-03-21
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2023-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-06
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2015-12-18
EJL Bur, Dental Dental Class 1 872.3240 2020-02-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-12-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-12-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-11-18
HTW Bit, Drill Orthopedic Class 1 888.4540 2015-12-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-12-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-12-18
GAD Retractor General, Plastic Surgery Class 1 878.4800 2020-09-23
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2016-02-16
LOD Bone Cement Orthopedic Class 2 888.3027 2016-02-16
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2016-02-16
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2016-02-16
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2018-12-18
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2020-09-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-10-20

Official Correspondent

Sofie Hoechstetter

US Agent Details

Jodie Gilmore Email: jodie.gilmore@elosmedtech.com Phone: (901) 8304552

Related Public Records

Same Entity

puracon GmbH
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 3004638532. Last updated year: 2026. Please use registration number 3004638532 when referencing this establishment in official correspondence.
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