FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
neon3
K Number: K150650
·
Decision Sep 24, 2015
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
112
Applicant Total
14
Review Days
196
Basic Information
- Device Name
- neon3
- K Number
- K150650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ULRICH GMBH & CO. KG
- Date Received
- March 12, 2015
- Decision Date
- September 24, 2015
- 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 |
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Other Clearances by ULRICH GMBH & CO. KG
| K Number | Device Name | ||
|---|---|---|---|
| K161032 | neon3 universal OCT spinal stabilization | Dec 22, 2016 | Substantially Equivalent |
| K122957 | TEZO TITANIUM CAGE FAMILY | Jun 21, 2013 | Substantially Equivalent |
| K123717 | UCENTUM | Mar 4, 2013 | Unknown |
| K120891 | TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM | Oct 1, 2012 | Substantially Equivalent |
| K113346 | NEON SYSTEM | Feb 28, 2012 | Substantially Equivalent |
| K103814 | PEZO INTERBODY CAGES SYSTEM | Mar 17, 2011 | Substantially Equivalent |
| K101353 | GOLDEN GATE ANTERIOR PLATE SYSTEM | Feb 4, 2011 | Substantially Equivalent |
| K102853 | FLAMENCO SPINAL FIXATION SYSTEM | Jan 25, 2011 | Substantially Equivalent |
| K090861 | MAMBO, MODEL CS 18XX-XX | May 21, 2010 | Substantially Equivalent |
| K090841 | ADDPLUS | Oct 5, 2009 | Substantially Equivalent |