FDA Registration
Active
🇩🇪 Germany
BIEDERMANN MOTECH GMBH & Co. KG
Reg #: 8010944
·
FEI: 3002806545
·
Expires 2026
Products
23
Proprietary Names
8
Establishment Types
4
Classifications
23
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Registration Details
- Registration Name
- BIEDERMANN MOTECH GMBH & Co. KG
- Registration Number
- 8010944
- FEI Number
- 3002806545
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BERTA-SUTTNER-STRASSE 23
- City
- VS-SCHWENNINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K162232
Owner / Operator
- Firm Name
- BIEDERMANN MOTECH GMBH & Co. KG
- Operator Number
- 8010944
- Address
- BERTHA-VON-SUTTNER-STRASSE 23, --
- City
- VILLINGEN-SCHWENNINGEN
- State
- Baden-Wurttemberg
- Postal Code
- D-78054
- Country
- DE
- Correspondent
- Gerd - Federle
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-12-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-12-18 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2017-07-26 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2016-12-22 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2007-11-16 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-12-09 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-12-09 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-12-09 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2016-12-22 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-12-22 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2016-12-22 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2016-12-22 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-08-30 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2020-04-02 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-06-09 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2016-12-22 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-03-01 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2016-12-22 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2016-12-22 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2016-12-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 1998-03-12 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-11-09 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2016-12-22 |
Proprietary Names
JAWS Nitinol Staples
Surgical Mesh
MOSS 100
MOSS Ti Pedicle Screw
MOSS Ti Rod
MOSS VRS
TELIX K Implant System
MOSS100 System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device