FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NorthStar OCT Spinal System
K Number: K193615
·
Decision Mar 25, 2020
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
66
Review Days
90
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Basic Information
- Device Name
- NorthStar OCT Spinal System
- K Number
- K193615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SeaSpine Orthopedics Corporation
- Date Received
- December 26, 2019
- Decision Date
- March 25, 2020
- 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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Infinity OCT System
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ANAX OCT Spinal System
FDA 510(k)
FDA Class 2
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Other Clearances by SeaSpine Orthopedics Corporation
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|---|---|---|---|
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| K240566 | Reef L Interbody System; WaveForm L Interbody System | Apr 26, 2024 | Substantially Equivalent |
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| K233694 | Meridian Interbody System; WaveForm A Interbody System | Jan 12, 2024 | Substantially Equivalent |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | Nov 28, 2023 | Substantially Equivalent |
| K232668 | Cove Strip, OsteoCove Strip | Sep 27, 2023 | Substantially Equivalent |
| K231030 | Cove Putty, OsteoCove Putty | Sep 14, 2023 | Substantially Equivalent |