FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNAPSE SYSTEM
K Number: K133698
·
Decision Jan 16, 2014
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
16
Review Days
44
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Basic Information
- Device Name
- SYNAPSE SYSTEM
- K Number
- K133698
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes USA Products, LLC
- Date Received
- December 3, 2013
- Decision Date
- January 16, 2014
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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Other Clearances by Synthes USA Products, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | Nov 21, 2018 | Substantially Equivalent |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | Dec 7, 2017 | Substantially Equivalent |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | May 8, 2017 | Substantially Equivalent |
| K170654 | USS System | Mar 29, 2017 | Substantially Equivalent |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw | Feb 16, 2017 | Substantially Equivalent |
| K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Nov 1, 2016 | Substantially Equivalent |
| K151276 | DePuy Synthes T-PAL Ti Spacer | Jun 18, 2015 | Substantially Equivalent |
| K143285 | Mandible External Fixator - MR Conditional | May 28, 2015 | Substantially Equivalent |
| K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Jan 20, 2015 | Substantially Equivalent |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | Sep 25, 2014 | Substantially Equivalent |