FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SPACE CPSXL BONE CEMENT
K Number: K072496
·
Decision Oct 5, 2007
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
5
Review Days
30
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Basic Information
- Device Name
- MODIFICATION TO SPACE CPSXL BONE CEMENT
- K Number
- K072496
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dfine, Inc.
- Date Received
- September 5, 2007
- Decision Date
- October 5, 2007
- Product Code
- NDN
- 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 |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | FDA class 2 | Orthopedic |
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Other Clearances by Dfine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091310 | ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 | Aug 11, 2010 | Substantially Equivalent |
| K090986 | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) | Dec 30, 2009 | Substantially Equivalent |
| K070351 | SPACE 360 DELIVERY SYSTEM | Jun 29, 2007 | Substantially Equivalent |
| K061531 | SPACE CPSXL BONE CEMENT | Aug 30, 2006 | Substantially Equivalent |