FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PCT System
K Number: K152211
·
Decision Dec 1, 2015
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
10
Review Days
116
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Basic Information
- Device Name
- PCT System
- K Number
- K152211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Centinel Spine, Inc.
- Date Received
- August 7, 2015
- Decision Date
- December 1, 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 Centinel Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | May 8, 2018 | Substantially Equivalent |
| K150053 | STALIF C; STALIF C-Ti | Jun 24, 2015 | Substantially Equivalent |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Jun 8, 2015 | Substantially Equivalent |
| K141942 | MIDLINE II TI | Nov 7, 2014 | Substantially Equivalent |
| K142079 | STALIF CTI, STALIF C | Oct 24, 2014 | Substantially Equivalent |
| K133200 | STALIF C(R) | May 8, 2014 | Substantially Equivalent |
| K133286 | MIDLINE (TM) | Jan 9, 2014 | Substantially Equivalent |
| K130461 | STALIF X | Aug 28, 2013 | Substantially Equivalent |
| K120819 | STALIF C | Aug 31, 2012 | Substantially Equivalent |