FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
K Number: K141385
·
Decision Mar 27, 2015
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
6
Applicant Total
1
Review Days
304
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Basic Information
- Device Name
- DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
- K Number
- K141385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5360
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Synthes Companies of Johnson & Johnson
- Date Received
- May 27, 2014
- Decision Date
- March 27, 2015
- Product Code
- HBW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBW | Fastener, Plate, Cranioplasty | FDA class 2 | Neurology |
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