FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
K Number: K092493
·
Decision Mar 29, 2010
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
2
Review Days
227
Basic Information
- Device Name
- GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
- K Number
- K092493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GPC MEDICAL LTD
- Date Received
- August 14, 2009
- Decision Date
- March 29, 2010
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by GPC MEDICAL LTD
| K Number | Device Name | ||
|---|---|---|---|
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | May 17, 2016 | Substantially Equivalent |