FDA Registration
Active
🇺🇸 United States
RSB SPINE LLC.
Reg #: 3003597504
·
FEI: 3003597504
·
Expires 2026
Products
52
Proprietary Names
9
Establishment Types
4
Classifications
52
Registration Details
- Registration Name
- RSB SPINE LLC.
- Registration Number
- 3003597504
- FEI Number
- 3003597504
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1877 Eagle Pass
- City
- Wooster
- State
- OH
- ZIP
- 44691
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071372
Owner / Operator
- Firm Name
- RSB SPINE LLC.
- Operator Number
- 9048490
- Address
- 1877 EAGLE PASS
- City
- Wooster
- State
- OH
- Postal Code
- 44691
- Country
- US
- Correspondent
- JOHN A REDMOND
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-01-15 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2025-01-15 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2008-11-04 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2025-02-03 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2010-10-06 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2010-10-06 |
| Specula Accessories | FXG | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-01-15 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-01-15 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2025-02-03 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Holder, Speculum, Ent | KAG | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2008-11-04 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2008-11-04 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2025-02-03 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2007-11-01 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Punch, Skull | GXJ | Class 1 | Neurology | No | 2025-01-15 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2026-04-16 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Speculum, Illuminated | FXF | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Speculum, Non-Illuminated | FXE | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
Proprietary Names
Redmed
rsb
InterPlate
InterPlate Spacer C-PS
InterPlate Spacer L-PS
InterPlate L-PS
InterPlate C-PS
InterPlate L-Ti
InterPlate C-Ti
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device