FDA Registration
Active
🇩🇪 Germany
Aristotech Industries GmbH
Reg #: 3014314623
·
FEI: 3014314623
·
Expires 2026
Products
28
Proprietary Names
100
Establishment Types
1
Classifications
28
Registration Details
- Registration Name
- Aristotech Industries GmbH
- Registration Number
- 3014314623
- FEI Number
- 3014314623
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Alt-Lankwitz 102
- City
- Berlin
- Country
- DE
Owner / Operator
- Firm Name
- Aristotech Industries GmbH
- Operator Number
- 10053573
- Address
- Im Biotechnologiepark
- City
- Luckenwalde
- State
- Brandenburg
- Postal Code
- 14943
- Country
- DE
- Correspondent
- Jens-Erik Wegner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-01-23 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-10-23 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2018-01-24 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2016-12-19 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2018-01-24 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2018-01-24 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-01-24 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2020-07-27 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-01-23 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2020-07-27 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2018-01-23 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-01-23 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2018-01-23 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-01-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-01-23 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2020-07-27 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-01-23 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2020-07-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-01-23 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2018-01-23 |
| Chisel, Mastoid | JYD | Class 1 | General, Plastic Surgery | No | 2020-07-27 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2018-01-23 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2020-07-27 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2020-07-27 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2018-01-23 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2020-07-27 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2018-01-23 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2020-07-27 |
Proprietary Names
OsteoBridge" IKA Knee Arthrodesis Torque Limiter
T-Handle
Wirefix Retractor
MetaStep" Saw Template
OsteoBridge" Trocar
OsteoBridge" IKA Knee Arthrodesis Cement Protection Cap
MetaStep" Stamp
Various handles with ratchet
Rasp Handle
MetaStep" Steinmann Nail
Chronoceptor"
OsteoBridge" IKA Knee Arthrodesis Distance Holder
MetaStep" Positioning Screw
MetaStep" Displacement Device
OsteoBridge" IDSF System Implants for Humerus, Tibia and Femur: Nails, Spacers, Connectors, Interlocking Screws
Merete Style 2 Locking Bone Plate (MTP Plate)
Tissue Protector
OsteoBridge" Drill Sleeve
Double Drill Sleeve
OsteoBridge" Protection Sleeve
OsteoBridge Drill Sleeve
OsteoBridge" IKA Knee Arthrodesis Guiding Pin
OsteoBridge" IKA Nail Guiding Impacting/Instrument
PediatrOS" FlexTack"/RigidTack" Target device
MetaFix" I Drill Guide
K-Wire
PediatrOS" FlexTack" Staples (20 mm, 25 mm and 30 mm)
PediatrOS" RigidTack" Staples (20 mm, 25 mm and 30 mm)
Merete Locking Screws dia 3 and 3.5 mm
Ludloff Osteotomy Fixation Clamp
Bone Clamp for Scarf Osteotomie
OsteoBridge" IDSF Diaphysis Spacer Clamp
MetaFix" LS Locking Screws
Merete Cannulated HCS
Merete CS Cortical Screws
Merete Cannulated PCS
TwistCut" Snap-Off Screws
TwistCut" Snap-Off Screw
OsteoBridge" IKA Knee Arthrodesis Impactor
PediatrOS" FlexTack"/RigidTack" Impactor
Bending Instrument
OsteoBridge" IKA Knee Arthrodesis Trial Nail
3D-Saw Template for Scarf/Chevron Osteotomie
OsteoBridge" IDSF Diaphysis Trial Nail
OsteoBridge" IDSF Diaphysis Spacer Gauge
Merete Style 13 Locking Bone Plate III (MetaStep" Calcaneus Plate)
Merete Cannulated PCS Plate Compression Screw
Merete Style 10 Locking Bone Plate III (MetaFix" Plantar BG10 Plate)
Merete CS Cortical Screw dia 3.5 mm fully / short threaded
Merete Style 12 Locking Bone Plate III (MetaFix" I Plate)
K-Wires
Merete Style 11 Locking Bone Plate III (MetaFix" PlantarMAX" Plate)
Merete CS Cortical Screw dia 3 mm fully / short threaded
MetaFix" LS Locking Screw dia 3.5 mm
MultiCup" Joint Screw Driver
OsteoBridge" IKA Knee Arthrodesis Screwdriver
OsteoBridge" Screwdriver
Various screwdrivers for foot surgeries
OsteoBridge" Drill
MultiCup" Joint Drill Bit
Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit)
Tap
Various Depth Gauges for Foot Surgery and OsteoBridge
Rasp for bone preparation
STERILIZING CASE
STORAGE
Steel Ruler
BONE SCREW RULER
PediatrOS" FlexTack"/RigidTack" Chisel
MetaCun" II Plate
Merete Style 6 Locking Bone Plate II (Open Wedge" Plate)
DuoMetaCun" II Plate
PediatrOS" FlexTack"/RigidTack" K-wire grip
Various Wrenches for orthopedic procedures
OsteoBridge IKA Knee Arthrodesis 10 Spacer
OsteoBridge IKA Knee Arthrodesis Nail without Collar
OsteoBridge IKA Knee Arthrodesis Nail with Collar
OsteoBridge Interlocking Screw
OsteoBridge" IKA Knee Arthrodesis Manual Awl
Merete Compression Screws dia 3, 4.3 and 6.5 mm
Merete CS Cortical Screw dia 3.5 mm fully threaded
Merete CS Cortical Screw dia 3 mm short threaded
Merete CS Cortical Screw dia 3 mm, fully threaded
Merete CS Cortical Screw dia 3.5 mm short threaded
PediatrOS" FlexTack"/RigidTack" Extractor
OsteoBridge" Extractor
Screw Extractor for cannulated Screws
BONE SCREW COUNTERSINK
OsteoBridge" IKA Knee Arthrodesis Nail with Collar dia and length extension
OsteoBridge" IKA Knee Arthrodesis Nail without Collar dia extension
OsteoBridge" IKA Knee Arthrodesis curved Nail without Collar
OsteoBridge" IKA Knee Arthrodesis Reamer
Spherical Reamer
MetaFix" I Screw dia 3.5 mm
MetaFix" I Small Locking Bone Plate
MetaFix" I Screw dia 3 mm
MECRON" Cannulated Screw System and Washers
Slotted Hammer
PediatrOS" FlexTack"/RigidTack" Slaphammer
Hammer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)