MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM— 510(k) K110655
Substantially EquivalentMahe Medical GmbH
FDA 510(k) clearance K110655 for MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM, Substantially Equivalent on 2011-10-27. Applicant: Mahe Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Mahe Medical GmbH
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Tuttlingen, Bw, GR
Recent devices under product code NKB
view all- K262091 — FRAXION Spinal Fixation System
- K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology +1 more
- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
More clearances from Mahe Medical GmbH
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.