Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015869121

FEI Number

3015869121

Entity Name

Jabil Switzerland Manufacturing GmbH (Raron)

City/State/Country

Raron Valais, CH

Establishment Address

Kanalsstrasse West 30, Raron Valais CH-3942, 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

SYNTHES (USA) LARGE FRAGMENT LOCKIN Plate, fixation, bone USS Synthes 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM Manual Orthopedic Instruments Instrument surgical instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT CHIA PERCPASSER, DePuy Mitek Instrument VELYS Active Robotic Assistance SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL HA Coated Schanz Screw DePuy Synthes Variable Angle Locking Patella Plating System HA COATED SCHANZ SCREWS washer,bolt,nut Synthes Dual-Opening USS SYNTHES CURVED RECONSTRUCTION PLATE SYNTHES LCP PROXIMAL HUMERUS PLATES MANDIBLE EXTERNAL FIXATOR DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM 3.5mm VA LCP Proximal TIbia Plate System TOMOFIX OSTEOTOMY SYSTEM Synthes 2.7mm LCP Ulna Osteotomy Plate System 4.5 MM LCP STRAIGHT RECONSTRUCTION TomoFix Medial High Tibia Pl. Small Synthes Self-Drilling Schanz Screws

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	2019-09-19
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2018-08-10
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
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	2019-05-02
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-01-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-19
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-28
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2019-04-30
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-04-28
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-09-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-04-30
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-09-20
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2019-09-18
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2019-04-29
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
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-09-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-20
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2019-09-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-30

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
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0012-06	N/A	2	EBI Trochanteric 11mm Long Nail.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015869121. Last updated year: 2026. Please use registration number 3015869121 when referencing this establishment in official correspondence.