FDA Registration
Active
🇺🇸 United States
MAXMORESPINE
Reg #: 3023155873
·
FEI: 3023155873
·
Expires 2026
Products
33
Proprietary Names
4
Establishment Types
1
Classifications
33
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Registration Details
- Registration Name
- MAXMORESPINE
- Registration Number
- 3023155873
- FEI Number
- 3023155873
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8659 Production Ave., Suite A
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K864402
Owner / Operator
- Firm Name
- Maxmorespine
- Operator Number
- 10086790
- Address
- 8659 Production Ave, Suite A
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Kenneth K Kleinhenz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2022-12-12 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2022-12-12 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2022-12-12 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Camera, Cine, Endoscopic, Without Audio | FWL | Class 1 | General, Plastic Surgery | No | 2023-05-23 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2022-12-12 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-12-13 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-12-12 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2022-12-12 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2022-12-12 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2022-12-13 |
| Probe | HXB | Class 1 | Orthopedic | No | 2022-12-12 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2023-01-20 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2022-12-12 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2022-12-12 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2022-12-12 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2022-12-12 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2022-12-12 |
Proprietary Names
maxmore Smart Pack System
Tactile Ball Hook - 400mm, 2.5mm
Needle Placer
BD Quincke Spinal Needle
Establishment Types
Complaint File Establishment per 21 CFR 820.198