KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set— 510(k) K171938
Substantially EquivalentMedtronic
FDA 510(k) clearance K171938 for KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set, Substantially Equivalent on 2017-10-23. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- Product code
- Code PML
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code PML
view all- K260286 — Dynamo Spinal Cement; Salvo® Spine System
- K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
- K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more
- K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement
More clearances from Medtronic
view all- K253530 — Trexon Monofilament Synthetic Absorbable Suture
- K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
- K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)
- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- K223494 — CD Horizon Spinal System
Adverse events under product code PML
product code PML- Death
- 8
- Total
- 8
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.