ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST— 510(k) K122037
Substantially EquivalentMedtronic Sofamor Danek, Inc.
FDA 510(k) clearance K122037 for ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST, Substantially Equivalent on 2013-03-22. Applicant: Medtronic Sofamor Danek, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Sofamor Danek, Inc.
- Product code
- Code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code MAX
view allMore clearances from Medtronic Sofamor Danek, Inc.
view all- K251193 — Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft
- K243706 — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules
- K230716 — Robotic Graft Delivery Instruments
- K141824 — MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP
- K140417 — DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
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.