FDA Registration
Active
🇺🇸 United States
AEGIS MEDITEC, INC.
Reg #: 3009790163
·
FEI: 3009790163
·
Expires 2026
Products
35
Proprietary Names
36
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- AEGIS MEDITEC, INC.
- Registration Number
- 3009790163
- FEI Number
- 3009790163
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 130 McCormick Ave, Suite 106
- City
- Costa Mesa
- State
- CA
- ZIP
- 92626
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223719
Owner / Operator
- Firm Name
- Aegis Spine
- Operator Number
- 10031416
- Address
- 130 McCormick Ave, Suite 106
- City
- Costa Mesa
- State
- CA
- Postal Code
- 92626
- Country
- US
- Correspondent
- Tony Ahn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2021-02-09 |
| Fork | HXE | Class 1 | Orthopedic | No | 2021-02-09 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2021-02-09 |
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2021-02-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-02-09 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2021-02-09 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2021-04-01 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2021-02-09 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-09-10 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-01-25 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2021-02-09 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2021-02-09 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-02-23 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2021-02-23 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2021-02-23 |
| Bender | HXW | Class 1 | Orthopedic | No | 2021-02-09 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2021-02-09 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2021-02-09 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2021-02-09 |
| File | HTP | Class 1 | Orthopedic | No | 2021-02-09 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2021-02-09 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2021-02-09 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2021-02-09 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2021-02-09 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2021-02-09 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2021-09-10 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2021-09-10 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2021-02-09 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2021-02-09 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-02-09 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2021-02-09 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2021-04-01 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2021-02-09 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2021-09-10 |
| Probe | HXB | Class 1 | Orthopedic | No | 2021-02-09 |
Proprietary Names
Bone Screw Starter
Fork
Impactor
Corkscrew
ZESPIN SI Joint Fusion System
Paeon Anterior Cervical Plate System
Paeon Posterior Cervical Fixation System
Elatus Lumbar Plate System
ABTross ALIF Expandable Cage System
Tamp
Dissector
Burr
TRAY, SURGICAL, INSTRUMENT
Wire Cutter
Orthopedic Surgical Scissors
ZESPINE SI Joint Fusion System
Bender
Compressor
Tap
Wrench
File
Knife
Guide Wire
Surgical Stripper
Rongeur
Reamer
Guide, surgical, instrument
CALIPER
Screw Driver
Extractor
Drill Bit
Broach
PIN GUIDE
Awl
DRIVER, PROSTHESIS
Probe
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility