FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
K Number: K150552
·
Decision Jun 4, 2015
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
172
Review Days
92
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
- K Number
- K150552
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- March 4, 2015
- Decision Date
- June 4, 2015
- Product Code
- NKG
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKG), ordered by most recent decision date.
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
FDA 510(k)
FDA Class 2
·Orthopedic
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Infinity OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
CMORE® CT System; CMORE® CT System Navigated Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
Infinity OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
ANAX OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Globus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | May 7, 2026 | Substantially Equivalent |
| K253401 | SCRIPT Implant System | Apr 29, 2026 | Substantially Equivalent |
| K261043 | AUTOBAHN Nailing System | Apr 24, 2026 | Substantially Equivalent |
| K252166 | RIB LINK Fixation System | Feb 26, 2026 | Substantially Equivalent |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Dec 22, 2025 | Substantially Equivalent |
| K250599 | ExcelsiusGPS Instruments | Nov 5, 2025 | Substantially Equivalent |
| K251161 | ANTHEM® Fracture System | Aug 18, 2025 | Substantially Equivalent |
| K241525 | ExcelsiusXR | Jul 8, 2025 | Substantially Equivalent |
| K243456 | ONVOY Acetabular System | Jun 6, 2025 | Substantially Equivalent |
| K243814 | NuVasive Pulse System | Jan 10, 2025 | Substantially Equivalent |