CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM— 510(k) K101235
Substantially EquivalentNeos Surgery S.L
FDA 510(k) clearance K101235 for CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM, Substantially Equivalent on 2010-10-25. Applicant: Neos Surgery S.L. Device class: 2.
Clearance details
- Applicant
- Neos Surgery S.L
- Product code
- Code GXR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alexandria, VA, US
Recent devices under product code GXR
view all- K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
- K221606 — Absorbable Cranial Flap Fixation System
- K192310 — Flap Fixator, Burr Hole Cover
- K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
More clearances from Neos Surgery S.L
view allData sourced from openFDA. This site is unofficial and independent of the FDA.