ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE— 510(k) K063100
Substantially EquivalentMedtronic Sofamor Danek, Inc.
FDA 510(k) clearance K063100 for ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE, Substantially Equivalent on 2007-02-23. Applicant: Medtronic Sofamor Danek, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Sofamor Danek, Inc.
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code KWQ
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 KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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 →
Recalls naming K063100
K-number listed on FDA's recall record- Z-0036-2013 — ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
- Z-0037-2013 — ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
- Z-0038-2013 — PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063100.
Data sourced from openFDA. This site is unofficial and independent of the FDA.