CLYDESDALE SPINAL SYSTEM— 510(k) K132897
Substantially EquivalentMedtronic Sofamor Danek, Inc.
FDA 510(k) clearance K132897 for CLYDESDALE SPINAL SYSTEM, Substantially Equivalent on 2013-12-11. 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
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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.