FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K Number: K161591
·
Decision Sep 21, 2016
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
172
Review Days
104
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Basic Information
- Device Name
- QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
- K Number
- K161591
- 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
- June 9, 2016
- Decision Date
- September 21, 2016
- 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.
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