FDA Registration
Active
🇩🇪 Germany
MERETE GMBH
Reg #: 3002949614
·
FEI: 3002949614
·
Expires 2026
Products
28
Proprietary Names
99
Establishment Types
1
Classifications
28
Registration Details
- Registration Name
- MERETE GMBH
- Registration Number
- 3002949614
- FEI Number
- 3002949614
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 102 ALT LANKWITZ
- City
- BERLIN
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K120978
Owner / Operator
- Firm Name
- MERETE GMBH
- Operator Number
- 9048847
- Address
- 102 ALT LANKWITZ, --
- City
- BERLIN
- State
- DE-NOTA
- Postal Code
- D-12247
- Country
- DE
- Correspondent
- Marc - Kneissler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-05-23 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2005-08-25 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2020-07-24 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2020-07-24 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2020-07-23 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2005-08-25 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2005-08-24 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2016-05-26 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-12-01 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2005-08-25 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2020-07-23 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2010-12-21 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2020-07-23 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2012-12-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2012-12-04 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2016-01-13 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2016-01-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-07-02 |
| Chisel, Mastoid | JYD | Class 1 | General, Plastic Surgery | No | 2020-07-23 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2005-08-25 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2020-07-23 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2020-07-24 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2005-08-25 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2005-08-25 |
| Template | HWT | Class 1 | Orthopedic | No | 2016-08-16 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2020-07-24 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2005-08-25 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2005-08-25 |
Proprietary Names
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
Various Depth Gauges for Foot Surgery and OsteoBridge
Hammer
PediatrOS FlexTack/RigidTack Slaphammer
Slotted Hammer
Rasp for bone preparation
OsteoBridge IKA Knee Arthrodesis Manual Awl
Bending Instrument
TwistCut Snap-Off Screw
Various Wrenches for orthopedic procedures
PediatrOS FlexTack/RigidTack K-wire grip
MECRON Cannulated Screw System and Washers
BONE SCREW COUNTERSINK
Spherical Reamer
OsteoBridge IKA Knee Arthrodesis Reamer
Merete Style 6 Locking Bone Plate II (Open Wedge Plate)
MetaCun II Plate
DuoMetaCun II Plate
OsteoBridge IDSF Diaphysis Spacer Clamp
Bone Clamp for Scarf Osteotomie
Ludloff Osteotomy Fixation Clamp
Merete Style 10 Locking Bone Plate III (MetaFix Plantar BG10 Plate)
Merete CS Cortical Screw dia 3 mm fully / short threaded
Merete Style 12 Locking Bone Plate III (MetaFix I Plate)
Merete CS Cortical Screw dia 3.5 mm fully / short threaded
MetaFix LS Locking Screw dia 3.5 mm
Merete Cannulated PCS Plate Compression Screw
K-Wires
Merete Style 13 Locking Bone Plate III (MetaStep Calcaneus Plate)
Merete Style 11 Locking Bone Plate III (MetaFix PlantarMAX Plate)
OsteoBridge IDSF System Implants for Humerus, Tibia and Femur: Nails, Spacers, Connectors, Interlocking Screws
PediatrOS FlexTack Staples (20 mm, 25 mm and 30 mm)
PediatrOS RigidTack Staples (20 mm, 25 mm and 30 mm)
MetaStep Stamp
MetaStep Displacement Device
MetaStep Steinmann Nail
Various handles with ratchet
Wirefix Retractor
MetaStep Saw Template
T-Handle
OsteoBridge IKA Knee Arthrodesis Distance Holder
OsteoBridge IKA Knee Arthrodesis Cement Protection Cap
MetaStep Positioning Screw
Chronoceptor
OsteoBridge Trocar
OsteoBridge IKA Knee Arthrodesis Torque Limiter
PediatrOS FlexTack/RigidTack Chisel
MultiCup Joint Screw Driver
OsteoBridge IKA Knee Arthrodesis Screwdriver
Various screwdrivers for foot surgeries
OsteoBridge Screwdriver
OsteoBridge IKA Knee Arthrodesis Impactor
PediatrOS FlexTack/RigidTack Impactor
Merete Locking Screws dia 3 and 3.5 mm
Merete Style 2 Locking Bone Plate (MTP Plate)
OsteoBridge Extractor
PediatrOS FlexTack/RigidTack Extractor
Screw Extractor for cannulated Screws
OsteoBridge IKA Knee Arthrodesis 10° Spacer
OsteoBridge IKA Knee Arthrodesis Nail with Collar
OsteoBridge Interlocking Screw
OsteoBridge IKA Knee Arthrodesis Nail without Collar
MetaFix LS Locking Screws
Merete® Cannulated HCS
Merete® Cannulated PCS
TwistCut Snap-Off Screws
Merete® CS Cortical Screws
Double Drill Sleeve
Tissue Protector
OsteoBridge Protection Sleeve
OsteoBridge Drill Sleeve
BioBall Offset Position Assistant
K-Wire
OsteoBridge IKA Nail Guiding Impacting/Instrument
PediatrOS FlexTack/RigidTack Target device
OsteoBridge IKA Knee Arthrodesis Guiding Pin
OsteoBridge Drill Sleeve
OsteoBridge Drill
MultiCup Joint Drill Bit
Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit)
OsteoBridge IDSF Diaphysis Trial Nail
OsteoBridge IDSF Diaphysis Spacer Gauge
OsteoBridge IKA Knee Arthrodesis Trial Nail
3D-Saw Template for Scarf/Chevron Osteotomie
Merete Compression Screws dia 3, 4.3 and 6.5 mm
Merete CS Cortical Screw dia 3 mm short threaded
Merete CS Cortical Screw dia 3.5 mm fully threaded
Merete CS Cortical Screw dia 3.5 mm short threaded
Merete CS Cortical Screw dia 3 mm, fully threaded
Tap
STERILIZING CASE
STORAGE
Steel Ruler
BONE SCREW RULER
MetaFix I Screw dia 3.5 mm
MetaFix I Small Locking Bone Plate
MetaFix I Screw dia 3 mm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility