MICRO PRECISION SWISS

FDA Device Registration & Listing · Santa Ana, CA, US · Registration 3005497913

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
3005497913
FEI Number
3005497913
Entity Name
MICRO PRECISION SWISS
City/State/Country
Santa Ana, CA, US
Establishment Address
3233 W Harvard St, Santa Ana, CA 92704, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MICRO PRECISION SWISS, LLC (Owner Number: 10042007)
Owner / Operator Contact Address
3233 West Harvard St, Santa Ana, CA 92704, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cruciform Bone Screw Cruciform screws Polarus Nail Blank Screws Retainer Ring Acu-Sinch Repair System and Acumed Suture Anchor iFuse Implant EZ Plate Screws Cheaspeake Lumbar Guided Drill Tapered Dense Bone Drill Guided Start Drill/Counterbore NobRpl Guided Dense Bone Drill Tapered Guided Screw Tap Tapered Guided Counterbore Drill Tapered 2.7mm Low Profile Hexalobe Screw Inset Reverse Total Shoulder System DigiFuse Intramedullary Fusion System Universal Wire Fixation Bolt - 23mm Hex Post - 40mm Hex Post - 60mm Hex Post - 20mm Universal Wire Fixation Bolt - 17.5mm Screwdriver Fixation Screw Implant Retrieval Instrument Abutment Screw Retrieval Instrument Acumed FFN 2.7mm NL CoCr Tiger 2 MIS – Screw Locking Driver CORTICAL BONE SCREW REFLECTION ACETABULAR SYSTEM TiMesh System Clavicle Sleeve Suture Anchor Suture Security Screw Extension Washer Denali mini EVOS SMALL FRAGMENT PLATING SYSTEM ASC Abutment Dynabolt Legacy Cover Screw Duo-Dent 05¿ Hex Driver, FP-20121 EVOS Tyber Medical Trauma Screw Apex Femoral Nailing System Everest Spinal System TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System for Rigid Fixation of the Bones of the Face and Sk K2 Hemi Toe Implant System EVOS RibLoc TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System Suture Security Screw Suture Anchor Clavicle Sleeve Extention washer TiMesh, Titanium Mesh Skeletal Orbit Liner Silverbolt/Mainframe Provisional Calf Support Provisional Midfoot Support Provisional Heel Support Orthopedic Manual Surgical Instrument AI TAB Acutrak 2 5.5 TiMesh System for Reconstructive Surgery and Rigid Fixation of the bones of the face and skull Screw-Vent Dental Implant System Armada SpheRx LEUCADIA AutoLok Pedicle Screw System Temporary Abutment Plastic SpheRx DBR II Spider Limited Wrist Fusion System SpheRx PPS Acumed 6.5 Cannulated CREO Stabilization System Total Foot System, Gen II NobelProcera PEEK Abutment MBA Subtalar Implant System Angulated Abutment

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2026-06-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-06-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-06-08
EGG Attachment, Precision, All Dental Class 1 872.3165 2019-01-03
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2013-02-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-09
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2013-05-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-06-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-08-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-08-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-12-31
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-12-31
DZI Drill, Bone, Powered Dental Class 2 872.4120 2012-11-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-02-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-02-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-02-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-02-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-02-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-02-20
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-03-21
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2022-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-12-31
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2015-04-09
HXX Screwdriver Orthopedic Class 1 888.4540 2013-03-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-02-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-01-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-01-20
QRQ Non-Irrigation Endosseous Dental Implant Drill Bits Dental Class 1 872.3980 2022-01-20
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2022-01-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-06-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-02-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-02-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-02-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-02-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-02-20
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-06-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-06-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-06-08
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-02-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-09-13
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2013-05-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-12-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-02-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-02-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-02-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-02-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-02-20
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-05-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-05-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-02-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-05-20
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-05-20
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-31
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-12-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-02-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-02-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-02-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-02-01
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-02-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-03-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-09-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-09-13
DZN Instruments, Dental Hand Dental Class 1 872.4565 2014-05-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-09
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-05-19
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2023-05-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-04-22
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-23
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2026-01-23
JEY Plate, Bone Dental Class 2 872.4760 2019-12-31
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2013-02-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-12-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-12-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-06-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-08
JEY Plate, Bone Dental Class 2 872.4760 2019-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-09
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2019-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-02-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-02-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-02-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-02-20
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-06-08
JEY Plate, Bone Dental Class 2 872.4760 2019-12-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-02-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-02-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-02-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-02-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-02-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-09
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-12-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-12-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-12-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-12-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-10-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-10-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-10-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-10-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-10-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-02-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-06-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-06-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-06-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-06-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-06-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-12-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-12-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-06-08
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-06-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-12-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-12-31
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2019-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-12-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-12-31
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-02-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-02-02

Official Correspondent

Joel Roth

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MICRO PRECISION SWISS, LLC
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
K020905 Biomet Orthopedics, Inc. NBX - NON-BRIDGING EXTERNAL FIXATOR 2002-04-15
K063832 Synthes (Usa) SYNTHES (USA) ELBOW HINGE FIXATOR 2007-03-07
K030390 Synthes (Usa) SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE 2003-04-01
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005497913. Last updated year: 2026. Please use registration number 3005497913 when referencing this establishment in official correspondence.
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