Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612277

FEI Number

3002807328

Entity Name

JAKUTEC MEDIZINTECHNIK GMBH & Co. KG

City/State/Country

LIPTINGEN Baden-Wurttemberg, DE

Establishment Address

AUF DER HOEHE 15, LIPTINGEN Baden-Wurttemberg 78576, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JAKUTEC Medizintechnik GmbH & Co. KG (Owner Number: 8010763)

Owner / Operator Contact Address

AUF DER HOEHE 15, --, LIPTINGEN, DE-BW 78576, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOPEDIC RONGEUR INNER NEEDLE STOPCOCK SPINAL CANNULA FLUID ADAPTOR Knife, orthopedic Endoscopic Self-Rightning Needle Holder (SRNH1) Endoscopic Needle Holder (E 705 R) FORCEPS ANNULATOME CURETTE SPOON DRILL BIT GUIDE HOOK PROBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-07-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-07-08
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2022-07-08
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2024-02-19
HTX	Rongeur	Orthopedic	Class 1	888.4540	2006-06-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-05-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-05-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-07-17
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2022-07-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-07-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-01-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-05-04
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2006-06-20
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2021-06-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-05-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-05-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-05-04
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-02-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-02-19
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1991-12-20
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1991-11-07
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2020-03-10
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1991-11-07
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2019-04-30
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2006-06-20
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2014-01-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-01-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-01-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-01-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-05-04
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-05-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-05-04
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2017-02-21
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2000-11-08
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-01-29
HXB	Probe	Orthopedic	Class 1	888.4540	2006-06-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-17
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-07-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-05-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-02-11
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-05-04

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

JAKUTEC Medizintechnik GmbH & Co. KG

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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

Similar Registrations

Registration Number	Establishment Name	Location
3043234953	ALLUMIN8 INC	Springfield, MO, US
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3004635447	C&W SWISS, INC.	CLAYTON, OH, US
3015869493	Jabil Switzerland Manufacturing GmbH (Mezzovico)	Mezzovico Ticino, CH
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612277. Last updated year: 2026. Please use registration number 9612277 when referencing this establishment in official correspondence.