KYPHX HV-R, MODEL C01A— 510(k) K033801
Substantially EquivalentKyphon, Inc.
FDA 510(k) clearance K033801 for KYPHX HV-R, MODEL C01A, Substantially Equivalent on 2004-04-01. Applicant: Kyphon, Inc.. Device class: 2.
Clearance details
- Applicant
- Kyphon, Inc.
- Product code
- Code NDN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code NDN
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 NDN
product code NDN- Death
- 24
- Injury
- 407
- Malfunction
- 1,975
- Total
- 2,406
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.