FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇭 Thailand
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
K Number: K103070
·
Decision Jan 12, 2011
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
2
Review Days
86
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Basic Information
- Device Name
- GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
- K Number
- K103070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- G Surgical Co., Ltd.
- Date Received
- October 18, 2010
- Decision Date
- January 12, 2011
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by G Surgical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K081041 | GPS, G SURGICAL PEDICLE SYSTEM | Jun 27, 2008 | Substantially Equivalent |