FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
K Number: K010246
·
Decision Feb 14, 2001
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
669
Applicant Total
9
Review Days
19
Basic Information
- Device Name
- KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
- K Number
- K010246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KYPHON, INC.
- Date Received
- January 26, 2001
- Decision Date
- February 14, 2001
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by KYPHON, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K073516 | DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR | Feb 21, 2008 | Substantially Equivalent |
| K063071 | DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B | Apr 13, 2007 | Substantially Equivalent |
| K061210 | FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B | Jun 27, 2006 | Substantially Equivalent |
| K041454 | KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A | Jul 9, 2004 | Substantially Equivalent |
| K041584 | KYPHX HV-R BONE CEMENT, MODEL C01A | Jul 7, 2004 | Substantially Equivalent |
| K033801 | KYPHX HV-R, MODEL C01A | Apr 1, 2004 | Substantially Equivalent |
| K032212 | KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A | Sep 15, 2003 | Substantially Equivalent |
| K981251 | KYPHON INFLATABLE BONE TAMP | Jul 2, 1998 | Substantially Equivalent |