KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A— 510(k) K032212
Substantially EquivalentKyphon, Inc.
FDA 510(k) clearance K032212 for KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A, Substantially Equivalent on 2003-09-15. Applicant: Kyphon, Inc.. Device class: 2.
Clearance details
- Applicant
- Kyphon, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code HRX
view allMore clearances from Kyphon, Inc.
view all- K073516 — DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
- K063071 — DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B
- K061210 — FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A; INTRODUCER NEEDLE, MODEL D01B
- K041454 — KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
- K041584 — KYPHX HV-R BONE CEMENT, MODEL C01A
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.