FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Typhoon(TM) Facet Screw Fixation System
K Number: K121850
·
Decision Sep 20, 2012
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
22
Review Days
87
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
- Typhoon(TM) Facet Screw Fixation System
- K Number
- K121850
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Choicespine, LP
- Date Received
- June 25, 2012
- Decision Date
- September 20, 2012
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRW), ordered by most recent decision date.
Ion-L
FDA 510(k)
FDA Unclassified
·Unknown
CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)
FDA 510(k)
FDA Unclassified
·Unknown
DiversiVy Facet Screw System
FDA 510(k)
FDA Unclassified
·Unknown
Ion-C
FDA 510(k)
FDA Unclassified
·Unknown
FFX Facet Fixation System
FDA 510(k)
FDA Unclassified
·Unknown
CORUS-LX Implant
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Choicespine, LP
| K Number | Device Name | ||
|---|---|---|---|
| K190227 | Boomerang Anterior Cervical Plate System | May 1, 2019 | Substantially Equivalent |
| K183397 | ChoiceSpine Stealth Cervical Spacer System | Mar 6, 2019 | Substantially Equivalent |
| K182721 | Choice Spine Navigation System | Jan 8, 2019 | Substantially Equivalent |
| K183214 | Raven Lumbar Plate System | Jan 3, 2019 | Substantially Equivalent |
| K180519 | HARRIER-SA Lumbar Interbody System | May 16, 2018 | Substantially Equivalent |
| K172816 | TiGer Shark System | Jan 26, 2018 | Substantially Equivalent |
| K173215 | Choice Spine Laminoplasty Fixation System | Jan 19, 2018 | Substantially Equivalent |
| K171489 | Acapella Cervical Spacer System | Oct 23, 2017 | Substantially Equivalent |
| K170821 | ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System | Jun 8, 2017 | Substantially Equivalent |
| K170942 | The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | Apr 26, 2017 | Substantially Equivalent |