FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KLS Martin Individual Patient Solutions
K Number: K163579
·
Decision Nov 21, 2017
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
20
Review Days
336
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Basic Information
- Device Name
- KLS Martin Individual Patient Solutions
- K Number
- K163579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KLS Martin L.P.
- Date Received
- December 20, 2016
- Decision Date
- November 21, 2017
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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|---|---|---|---|
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| K220050 | KLS Martin IPS Distraction | Aug 11, 2022 | Substantially Equivalent |
| K173320 | KLS Martin L1 MMF System | Feb 23, 2018 | Substantially Equivalent |
| K163315 | Internal Distraction - Sterile | May 5, 2017 | Substantially Equivalent |
| K170124 | Level One Hand Plating System | Mar 9, 2017 | Substantially Equivalent |
| K161259 | KLS Martin Cannulated Headless Screws | Dec 19, 2016 | Substantially Equivalent |
| K161470 | Internal Distraction - Sterile | Dec 1, 2016 | Substantially Equivalent |
| K151983 | KLS Martin LSS Plating System | Apr 6, 2016 | Substantially Equivalent |