FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NorthStar OCT System
K Number: K231654
·
Decision Aug 3, 2023
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
27
Review Days
58
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Basic Information
- Device Name
- NorthStar OCT System
- K Number
- K231654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seaspine, Inc.
- Date Received
- June 6, 2023
- Decision Date
- August 3, 2023
- 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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Other Clearances by Seaspine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150469 | Integra Laminoplasty System | Mar 23, 2015 | Substantially Equivalent |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene | Dec 18, 2014 | Substantially Equivalent |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | May 1, 2014 | Substantially Equivalent |
| K132859 | INTEGRA FACET FIXATION SYSTEM | Nov 18, 2013 | Substantially Equivalent |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | Sep 4, 2013 | Substantially Equivalent |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | May 9, 2013 | Substantially Equivalent |
| K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | Dec 12, 2012 | Substantially Equivalent |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Jan 25, 2012 | Substantially Equivalent |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Dec 28, 2011 | Substantially Equivalent |
| K102026 | SEASPINE SPACER SYSTEM | May 12, 2011 | Substantially Equivalent |