Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015869493

FEI Number

3015869493

Entity Name

Jabil Switzerland Manufacturing GmbH (Mezzovico)

City/State/Country

Mezzovico Ticino, CH

Establishment Address

Via Cavazz 5, Mezzovico Ticino CH-6805, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jabil Inc. (Owner Number: 9074019)

Owner / Operator Contact Address

10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

USS DePuy Synthes Cortex and Cannulated Screws SYNTHES (USA) 3.5MM CONICAL SCREWS SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM guide Guide, Surgical Instrument Guide Block Drill Sleeve Sternal Fixation System VOLT Locking and Cancellous Screws VOLT Small Fragment Plating System VOLT Mini Fragment Plating System DePuy Synthes VOLT Mini Fragment Plating System SYNFIX Lateral 2.4mm Variable Angle LCP Volar Rim Distal Radius System Smooth threaded metallic bone fix SYNTHES ANATOMICAL LOCKING PLATE SYSTEM TOMOFIX OSTEOTOMY SYSTEM Manual Orthopedic Instruments Instrument surgical instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT CHIA PERCPASSER, DePuy Mitek Instrument SYNTHES (USA) LARGE FRAGMENT LOCKIN SYNTHES USS (10MM SIDE OPENING SCREWS ANTERIOR CSLP SYSTEM 2.4mm VA LCP Two Column Volar DR 3.5mm LCP Hook Plates DePuy Synthes 2.7mm VA LCP Clavicle Plate System/ DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System Synthes Large Ex Fix, MR Cond. HA Coated Schanz Screw washer,bolt,nut Synthes2.4 LCP Vol. Col. Dist. Radi DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long SYNTHES SYNEX SPACER SYSTEM SYNTHES (USA) LCP MODULAR FOOT PLATES SYNTHES (USA) ALVEOLAR RIDGE DISTRA SYNTHES BUTTON PLATE SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM Synthes Dual-Opening USS HINDFOOT ARTHRODESIS NAIL Synthes MatrixMANDIBLE Preformed Re MATRIXRIB FIXATION SYSTEM SYNTHES USS, CLICK`X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS SYNTHES UNIVERSAL SPINAL SYSTEM VOLT Proximal Humerus 3.5 Plating System MIRS SynCage Evolution Spacer Zero-P VA Synthes Zero-P VA Matrix Sagittal Screws DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System HA Coated Schanz Screw Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins Synthes Matrix MIS Rods DePuy Synthes 2.7mm Straight And 2.7mm Adaption Plates (Modular Mini Fragment LCP System) SYNTHES VA LCP ANKLE TRAUMA SYSTEM template MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK Synthes Locking Hand Plates T-PAL Ti Spacer Small Stature Ant. Cerv. Vertebral SYNAPSE SYSTEM TriALTIS Spine System Synthes Cortical Screws SYNFIX Evolution Synthes T-PAL Spacer Synthes (USA) VA-LCP 2-Col Narrow DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System Synthes ClampFix System Plate, fixation, bone Plate fixation, bone

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-09-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2019-04-29
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-03-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-05-02
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-09-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-09-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-09-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-09-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-01-15
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-09-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-01
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-04-29
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-01
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-04-29
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-09-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-05-02
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2019-09-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2019-09-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-09-19
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2019-09-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
JDP	Condylar Plate Fixation Implant	Orthopedic	Class 2	888.3030	2019-04-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-04-30
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-08
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-08
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-05-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-09-19
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2018-08-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-10-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-09-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-09-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-09-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-09-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-09-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-09-20
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-09-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-09-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-09-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-09-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-09-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-14
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2019-04-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-04-28
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2019-09-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-09-19
JDP	Condylar Plate Fixation Implant	Orthopedic	Class 2	888.3030	2019-09-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-09-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-09-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-09-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-09-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-09-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-06-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
HWT	Template	Orthopedic	Class 1	888.4800	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-09-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-09-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-09-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-09-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-02-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-28
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-04-30
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-09-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-09-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-13
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-05-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-05-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-05-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-05-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-05-02
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-04-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-04-29
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-01

Official Correspondent

No official correspondent registered.

US Agent Details

Lex Pearce Business: JABIL - NYPRO HEALTHCARE DIVISION Email: lex_pearce@jabil.com Phone: (505) 2030277

Related Public Records

Same Entity

Jabil Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
3011246727	Jabil Circuit Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3003512059	NYPRO DR, LLC (Bldg 11)	Haina San Cristobal, DO
3004730544	NYPRO DR, LLC (Building 52)	Haina San Cristobal, DO
1424235	Nypro Inc. (Chicago)	GURNEE, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015869493. Last updated year: 2026. Please use registration number 3015869493 when referencing this establishment in official correspondence.