ONYX MEDICAL LLC

FDA Device Registration & Listing · MEMPHIS, TN, US · Registration 1043653

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
1043653
FEI Number
1043653
Entity Name
ONYX MEDICAL LLC
City/State/Country
MEMPHIS, TN, US
Establishment Address
1800 North Shelby Oaks Drive, MEMPHIS, TN 38134, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Elos Medtech Onyx (Owner Number: 9002922)
Owner / Operator Contact Address
1800 N Shelby Oaks Dr, --, Memphis, TN 38134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Biomet Headless Compression And Twist-Off Screws Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Plate, Fixation, Bone DePuy Synthes HEX-FIX Bone Pins CAS Fix fluted 3.2mm Stryker Instratek CAS Fix fluted 3.2mm Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Plate, Fixation, Bone XTRAFIX JOURNEY Pin, Fixation, Threaded T2 ICF System Half Pin JOURNEY Ace ALPS Proximal Humerus Plating System D-RAD Smart Pack JOURNEY Bone Pins Biomet Headless Compression And Twist-Off Screws CAS Fix fluted 3.2mm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-06
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2015-03-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-01-16
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-01-16
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-12-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
LRN Wire, Surgical Orthopedic Class 2 888.3030 2012-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2015-03-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2013-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-09-10
FXZ Helmet, Surgical General, Plastic Surgery Class 1 878.4040 2017-04-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-04-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-04-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-04-20
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2015-03-03
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2013-01-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2013-02-01
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2024-01-10
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2020-06-02
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-23
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2013-01-23
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2013-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2015-12-14
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2015-03-03
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2013-01-28
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-12-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-01-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-22
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2015-07-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-07-22
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2017-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-28
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-14
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-12-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-14
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-14
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2013-02-14
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-01-28
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2017-09-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-12-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-08
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-03-02
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-06
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2020-09-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-14
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2013-01-14
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2017-03-01
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-03-01
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-04
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-01-22
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2020-01-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-12-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2015-03-02
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2013-01-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-03-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-03-02
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-12-29
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-12-29
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-06-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-03-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-01-16
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-11-12
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2018-11-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-07
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-28
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2014-10-23
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2015-12-09
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-03-01
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-12-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-06-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-14
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2015-03-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-03-03
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2015-03-03
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2015-03-03
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2015-03-03
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2015-03-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-03-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2015-03-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-01
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-04-20
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2017-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-14
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-12-29
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-06-02
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2017-03-01
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2015-03-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2015-12-09
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2013-02-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-02-01
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2015-12-07
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2013-02-14
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-02-14
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-02-14
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-04-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2015-03-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-07-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-02-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-03-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-14
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2013-02-14
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-06-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-29
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2015-12-07
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic Class 2 888.3800 2016-03-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-04-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-04-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-04-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-04-20
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2020-06-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-06-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2017-01-16
HNO Keratome, Ac-Powered Ophthalmic Class 1 886.4370 2017-01-16
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-14
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-01-23
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-03-17
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2012-12-29
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-12-29
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2015-07-22
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2015-07-22
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2015-07-22
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2015-07-22
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2015-07-22
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2015-07-22
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2015-07-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-07-22
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2015-07-22
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2015-07-22
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2015-07-22
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-07-22
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2015-07-22
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2012-12-29
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2017-01-16
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-12-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-01-02
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-02-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-02-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2017-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-06
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-06
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-02-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2016-02-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-28
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-12-06
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2015-03-02

Official Correspondent

Jodie Gilmore

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elos Medtech Onyx
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
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043653. Last updated year: 2026. Please use registration number 1043653 when referencing this establishment in official correspondence.
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