FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Range/Denali/Mesa Spinal System
K Number: K171832
·
Decision Sep 14, 2017
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
19
Review Days
86
Basic Information
- Device Name
- Range/Denali/Mesa Spinal System
- K Number
- K171832
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2M, Inc.
- Date Received
- June 20, 2017
- Decision Date
- September 14, 2017
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKB), ordered by most recent decision date.
KHEIRON® Spinal Fixation System, including patient specific K-ROD
FDA 510(k)
FDA Class 2
·Orthopedic
Momentum® Posterior Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Virata Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
Annex® 2 Adjacent Level System
FDA 510(k)
FDA Class 2
·Orthopedic
COLONNADE Posterior Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by K2M, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211320 | CAPRI Corpectomy Cage System | Feb 24, 2022 | Substantially Equivalent |
| K201006 | K2M Navigation Instruments | Aug 7, 2020 | Substantially Equivalent |
| K193203 | MOJAVE Expandable Interbody System | Feb 18, 2020 | Substantially Equivalent |
| K193129 | Yukon OCT Spinal System | Feb 7, 2020 | Substantially Equivalent |
| K192911 | Brainlab Compatible K2M Navigation Instruments | Nov 14, 2019 | Substantially Equivalent |
| K190179 | SAHARA Stabilization System | Oct 3, 2019 | Substantially Equivalent |
| K180777 | K2M Expandable Interbody System | Aug 3, 2018 | Substantially Equivalent |
| K181119 | Range (Denali and Mesa) Spinal Systems | Jun 26, 2018 | Substantially Equivalent |
| K180376 | K2M Patient Specific Rods | Apr 5, 2018 | Substantially Equivalent |
| K172009 | Cascadia Interbody System | Dec 14, 2017 | Substantially Equivalent |