FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-JAWS CERVICAL COMPRESSIVE STAPLE
K Number: K133906
·
Decision Jul 24, 2014
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
1
Applicant Total
17
Review Days
213
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Basic Information
- Device Name
- C-JAWS CERVICAL COMPRESSIVE STAPLE
- K Number
- K133906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicrea International
- Date Received
- December 23, 2013
- Decision Date
- July 24, 2014
- Product Code
- PHQ
- 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 |
|---|---|---|---|
| PHQ | Anterior Staple As Supplemental Fixation For Fusion | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PHQ), ordered by most recent decision date.
View allOther Clearances by Medicrea International
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| K180091 | UNiD Spine Analyzer | Feb 8, 2018 | Substantially Equivalent |
| K170172 | UNiD Spine Analyzer | May 24, 2017 | Substantially Equivalent |
| K153169 | PASS OCT Patient Specific Rods | Jan 29, 2016 | Substantially Equivalent |
| K150049 | PASS LP Spinal System | Feb 10, 2015 | Substantially Equivalent |
| K140738 | PASS LP SPINAL SYSTEM | Nov 4, 2014 | Substantially Equivalent |
| K132395 | LIGAPASS | Dec 6, 2013 | Substantially Equivalent |
| K132574 | PASS LP SPINAL SYSTEM | Nov 8, 2013 | Substantially Equivalent |
| K132575 | PASS LP SPINAL SYSTEM | Oct 3, 2013 | Substantially Equivalent |