FDA Registration
Active
🇨🇭 Switzerland
LEITNER AG
Reg #: 3009381600
·
FEI: 3009381600
·
Expires 2026
Products
23
Proprietary Names
21
Establishment Types
1
Classifications
23
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Registration Details
- Registration Name
- LEITNER AG
- Registration Number
- 3009381600
- FEI Number
- 3009381600
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Amselweg 1
- City
- Busswil Bern
- Country
- CH
Owner / Operator
- Firm Name
- Leitner AG
- Operator Number
- 10049857
- Address
- Amselweg 1
- City
- Busswil
- State
- Bern
- Postal Code
- 3292
- Country
- CH
- Correspondent
- Ronnie Hirsbrunner
US Agent
- Business Name
- LDJCG LLC
- Contact Name
- Lance Johnson
- Address
- 102 Bobwhite Cove
- City
- Dripping Springs
- State
- TX
- ZIP
- 78620
- Country
- US
- [email protected]
- Phone
- 512 7757610
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-07-11 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2024-07-04 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-12-12 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-12-12 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2016-01-27 |
| Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | NXT | Class 3 | Unknown | No | 2016-12-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2025-05-28 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2017-02-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-08-30 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2018-03-27 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2017-02-20 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2024-07-04 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2018-07-13 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-07-13 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2015-08-27 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2017-02-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-06-30 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2017-04-25 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2016-08-05 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2018-03-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-08-27 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-03-27 |
Proprietary Names
Bonebridge - Screwdriver 2.5mm
Bonebridge - Screwdriver 3.5mm
Smith-Nephew
Trial Implants
DepuySynthes
Zimmer Biomet
Bonebridge - Monoaxial Drill Guide
Bonebridge - Insert Monoaxial Drill Guide
Bonebridge - Exchangeable Bit 2.5mm
Bonebridge - Exchangeable Bit 3.5mm (short 100mm)
Bonebridge - Exchangeable Bit 3.5mm (long 180mm)
Intervertebral Body Fusion Device
Arthrex
T2 ICF System
Forceps
Double Drill Guide for Compr. / Neutr.
Globus Medical
Medartis
Implantcast - ankle clamp
Implantcast - intramedullary rod
Double Drill Guide
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)