FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
K Number: K070731
·
Decision Jul 31, 2007
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
5
Review Days
138
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Basic Information
- Device Name
- PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
- K Number
- K070731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Plus Orthopedics AG
- Date Received
- March 15, 2007
- Decision Date
- July 31, 2007
- Product Code
- HAW
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Plus Orthopedics AG
| K Number | Device Name | ||
|---|---|---|---|
| K070928 | CERAMIC BALL HEADS, 28, 32 AND 36 MM | Aug 1, 2007 | Substantially Equivalent |
| K070278 | POLARCUP DUAL MOBILITY SYSTEM | Apr 16, 2007 | Substantially Equivalent |
| K063578 | PROMOS MODULAR SHOULDER SYSTEM | Mar 2, 2007 | Substantially Equivalent |
| K061362 | PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM | Oct 6, 2006 | Substantially Equivalent |