FDA Registration
Active
🇺🇸 United States
BIOGENNIX, LLC
Reg #: 3008773560
·
FEI: 3008773560
·
Expires 2026
Products
15
Proprietary Names
24
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- BIOGENNIX, LLC
- Registration Number
- 3008773560
- FEI Number
- 3008773560
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18009 Sky Park Cir Ste K
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190177
Owner / Operator
- Firm Name
- Biogennix, LLC
- Operator Number
- 10030571
- Address
- 18007 Sky Park Circle, Suite D
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
- Correspondent
- Edwin C Shors
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-12-21 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-12-21 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2020-09-24 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2020-09-24 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2019-08-13 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-12-21 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2017-12-21 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2017-12-21 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2017-12-21 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2017-12-21 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2017-12-21 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-02-15 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-02-15 |
Proprietary Names
Articulating Awl Guide
Slap Hammer
Instrument Tray with Caddy
Cover Plate Driver with Torque Handle
Angulating Screwdriver with Handle
Straight Screwdriver with Handle
Direct Cell
Agilon
Agilon Strip
Trials with Trial Inserter
Rasps with Rasp Inserter
Bullet Distractors with Bullet Distractor Inserter
Tamp
Spacer Remover
Agilon Moldable
Simple Inserter
Morpheus
PURcore
MAC-Fuse
PRY-Fuse
Angulating Awl with Handle
Safety Awl
Sypher ALIF Spacer System
OsteoSpan
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device