Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017521423

FEI Number

3017521423

Entity Name

Jabil Tuttlingen Manufacturing GmbH

City/State/Country

Tuttlingen Baden-Wurttemberg, DE

Establishment Address

Unter Hasslen 5, Tuttlingen Baden-Wurttemberg 78532, DE

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

REAMER (MULTIPLE BRANDS) Zero-P VA Synthes Zero-P VA SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM Gouge, surgical, general & plastic surgery SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS guide Guide, Surgical Instrument Guide Block Drill Sleeve dissector Clamp, Surgical, General & Plastic Surgery forceps Bending Iron Instrument, Bending Or Contouring SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM SOCKET PUSHER RONGEUR MALLETS HANDLE, SCALPEL Handle hook hammer T-PAL Ti Spacer Saw Blade template chisel SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR bender WIRE TWISTER countersink Punch cutter Forceps instrument Cannulated Reduction Tool cutter Screwdriver SCREWDRIVER (MULTIPLE BRANDS) stylet Depth Gauge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-04-29
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2019-04-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-04-30
HTO	Reamer	Orthopedic	Class 1	888.4540	2019-03-08
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	2019-03-08
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-10-25
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-02
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-04-29
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-04-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-03-08
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2019-04-29
HXW	Bender	Orthopedic	Class 1	888.4540	2019-04-29
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-08-13
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-04-29
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-09-23
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2020-10-25
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2019-04-29
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2019-04-29
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2019-04-29
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-04-29
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2019-04-29
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-08
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2019-04-28
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-08
HXG	Tamp	Orthopedic	Class 1	888.4540	2019-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-04-29
HTX	Rongeur	Orthopedic	Class 1	888.4540	2020-10-25
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2020-10-25
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-08-26
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2019-09-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-09-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-09-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2019-05-02
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2018-08-10
HWT	Template	Orthopedic	Class 1	888.4800	2019-04-29
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2018-08-13
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2018-08-14
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-04-30
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2019-09-23
HWW	Countersink	Orthopedic	Class 1	888.4540	2019-09-23
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-10-25
HXB	Probe	Orthopedic	Class 1	888.4540	2019-04-29
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-04-29
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2019-04-29
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2019-09-20
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2019-04-26
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-04-29
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2019-04-29

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
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-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
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 3017521423. Last updated year: 2026. Please use registration number 3017521423 when referencing this establishment in official correspondence.