FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEASPINE MONOPOLAR PROBE SYSYEM
K Number: K111671
·
Decision Dec 28, 2011
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
96
Applicant Total
27
Review Days
196
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
- SEASPINE MONOPOLAR PROBE SYSYEM
- K Number
- K111671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seaspine, Inc.
- Date Received
- June 15, 2011
- Decision Date
- December 28, 2011
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETN), ordered by most recent decision date.
Evala Nerve Stimulator (EPNR002)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Bioscope Neuromonitor Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EARP Nerve Cuff Electrode
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Disposable Laryngeal Electrodes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Seaspine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231654 | NorthStar OCT System | Aug 3, 2023 | Substantially Equivalent |
| 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 |
| K102026 | SEASPINE SPACER SYSTEM | May 12, 2011 | Substantially Equivalent |