FDA Registration
Active
🇩🇪 Germany
JAKUTEC MEDIZINTECHNIK GMBH & Co. KG
Reg #: 9612277
·
FEI: 3002807328
·
Expires 2026
Products
35
Proprietary Names
14
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- JAKUTEC MEDIZINTECHNIK GMBH & Co. KG
- Registration Number
- 9612277
- FEI Number
- 3002807328
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- AUF DER HOEHE 15
- City
- LIPTINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- JAKUTEC Medizintechnik GmbH & Co. KG
- Operator Number
- 8010763
- Address
- AUF DER HOEHE 15, --
- City
- LIPTINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78576
- Country
- DE
US Agent
- Business Name
- Business Support International
- Contact Name
- Angelika Scherp
- Address
- 1350 Avenue of the Americas, 2nd Floor
- City
- Manhattan
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 212 3318358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-07-08 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-07-08 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2022-07-08 |
| Table, Surgical With Orthopedic Accessories, Manual | JEB | Class 1 | General, Plastic Surgery | No | 2024-02-19 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2006-06-20 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-07-17 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2022-07-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-07-17 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-01-27 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2006-06-20 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2021-06-17 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-05-04 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-05-04 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2024-02-19 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1991-12-20 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1991-11-07 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2020-03-10 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1991-11-07 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2019-04-30 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2006-06-20 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2014-01-28 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2017-02-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2000-11-08 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2008-01-29 |
| Probe | HXB | Class 1 | Orthopedic | No | 2006-06-20 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-07-17 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-07-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-07-17 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2001-01-22 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-09-21 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-02-21 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2008-01-16 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1991-12-02 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2000-12-14 |
| Prosthesis, Posterior Spinal Elements | QWK | Class 3 | Unknown | No | 2025-02-11 |
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)