FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES ORACLE SPACER
K Number: K062933
·
Decision Jan 31, 2007
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
18
Review Days
125
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Basic Information
- Device Name
- SYNTHES ORACLE SPACER
- K Number
- K062933
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes Spine Co.Lp
- Date Received
- September 28, 2006
- Decision Date
- January 31, 2007
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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Other Clearances by Synthes Spine Co.Lp
| K Number | Device Name | ||
|---|---|---|---|
| K121852 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | Jul 25, 2012 | Substantially Equivalent |
| K112459 | SYNTHES ZERO-P | Dec 12, 2011 | Substantially Equivalent |
| K112068 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | Nov 7, 2011 | Substantially Equivalent |
| K103320 | SYNTHES XRL | Oct 20, 2011 | Substantially Equivalent |
| K081568 | ANTEGRA-T | Sep 2, 2008 | Substantially Equivalent |
| K080020 | ARCOFIX | May 23, 2008 | Substantially Equivalent |
| K072981 | SYNTHES ZERO-P | Feb 11, 2008 | Substantially Equivalent |
| K072434 | SYNTHES OC FUSION AND SYNAPSE SYSTEMS | Jan 10, 2008 | Substantially Equivalent |
| K072253 | SYNFIX-LR SPACER | Oct 12, 2007 | Substantially Equivalent |
| K070573 | SYNAPSE SYSTEM | Jun 8, 2007 | Substantially Equivalent |