FDA Registration
Active
🇺🇸 United States
ELEVATION SPINE
Reg #: 3015991317
·
FEI: 3015991317
·
Expires 2026
Products
12
Proprietary Names
102
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- ELEVATION SPINE
- Registration Number
- 3015991317
- FEI Number
- 3015991317
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2511 Garden Road, Suite B125
- City
- Monterey
- State
- CA
- ZIP
- 93940
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190885
Owner / Operator
- Firm Name
- Elevation Spine
- Operator Number
- 10061171
- Address
- 2511 Garden Road, Suite B125
- City
- Monterey
- State
- CA
- Postal Code
- 93940
- Country
- US
- Correspondent
- Christine Scifert
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Template | HWT | Class 1 | Orthopedic | No | 2022-12-14 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2024-01-17 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2024-01-17 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2022-12-14 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-09-04 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-09-04 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-09-04 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2022-12-14 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-12-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-12-14 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2022-12-14 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2022-12-14 |
Proprietary Names
Trial Head 14x17x5 9 deg.
Trial Head 15x18x6 0 deg.
Trial Head 14x17x7 6 deg.
Trial Head 15x18x5 6 deg.
Trial Head 14x15x6 9 deg.
Trial Head 14x17x8 9 deg.
Trial Head 12x15x7 6 deg.
Trial Head 14x17x6 0 deg.
Trial Head 15x18x7 0 deg.
Trial Head 12x15x6 9 deg.
Trial Head 15x18x10 0 deg.
Trial Head 14x17x10 0 deg.
Trial Head 12x15x10 0 deg.
Trial Head 15x18x7 6 deg.
Trial Head 15x18x10 9 deg.
Trial Head 14x15x10 9 deg.
Trial Head 14x15x9 0 deg.
Trial Head 14x17x7 0 deg.
Trial Head 15x18x9 9 deg.
Trial Head 14x15x10 6 deg.
Trial Head 14x15x10 0 deg.
Trial Head 14x17x9 6 deg.
Trial Head 14x17x8 6 deg.
Trial Head 12x15x6 0 deg.
Trial Head 12x15x10 6 deg.
Trial Head 12x15x6 6 deg.
Trial Head 15x18x8 6 deg.
Trial Head 15x18x10 6 deg.
Trial Head 14x17x6 9 deg.
Trial Head 12x15x8 6 deg.
Trial Head 14x15x6 0 deg.
Trial Head 15x18x5 0 deg.
Trial Head 15x18x8 9 deg.
Trial Handle
Trial Head 12x15x9 6 deg.
Trial Head 14x17x8 0 deg.
Trial Head 14x15x8 9 deg.
Trial Head 14x17x6 6 deg.
Trial Head 14x17x10 9 deg.
Trial Head 14x15x9 9 deg.
Trial Head 14x15x6 6 deg.
Trial Head 14x17x5 0 deg.
Trial Head 15x18x7 9 deg.
Trial Head 12x15x8 9 deg.
Trial Head 15x18x6 6 deg.
Trial Head 15x18x9 6 deg.
Trial Head 15x18x8 0 deg.
Trial Head 12x15x5 9 deg.
Trial Head 12x15x9 9 deg.
Trial Head 12x15x7 0 deg.
Trial Head 14x15x7 6 deg.
Trial Head 15x18x9 0 deg.
Trial Head 14x17x9 9 deg.
Trial Head 14x15x9 6 deg.
Trial Head 14x17x5 6 deg.
Trial Head 14x15x5 6 deg.
Trial Head 14x17x9 0 deg.
Trial Head 12x15x5 6 deg.
Trial Head 14x15x8 6 deg.
Trial Head 14x15x5 0 deg.
Trial Head 14x15x8 0 deg.
Trial Head 14x17x10 6 deg.
Trial Head 15x18x5 9 deg.
Trial Head 12x15x8 0 deg.
Trial Head 14x15x5 9 deg.
Trial Head 14x15x7 9 deg.
Trial Head 12x15x5 0 deg.
Trial Head 12x15x9 0 deg.
Trial Head 15x18x6 9 deg.
Trial Head 14x17x7 9 deg.
Trial Head 14x15x7 0 deg.
Trial Head 12x15x10 9 deg.
Trial Head 12x15x7 9 deg.
TRAY
RASP
Screw Handle
Saber-C System
Awl, Straight
Handle (Awl, Drill)
Spike Driver (Final)
Spike Driver, 8-9mm
Assembly tool
Inserter
Spike Driver
Spike Extractor
Carriage 9mm
Locking Plate Inserter
Guide, 10mm
Carriage 5-6mm
Spike Driver, 10mm
Spike Removal Tool
Carriage 10mm
Carriage 8mm
Carriage 7mm
Guide, 7mm
Guide, 8mm
Spike Driver, 5-7mm
Guide, 9mm
Guide, 5-6mm
Drill, Straight
Screw Driver
Mallet
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility