OSSDSIGN Cranioplug— 510(k) K181539
Substantially EquivalentOssdsign AB
FDA 510(k) clearance K181539 for OSSDSIGN Cranioplug, Substantially Equivalent on 2018-10-12. Applicant: Ossdsign AB. Device class: 2.
Clearance details
- Applicant
- Ossdsign AB
- 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
- Uppsala, SE
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 Ossdsign AB
view all- K232315 — Catalyst Bone Void Filler
- K212414 — OSSDSIGN Cranial PSI
- K190523 — Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial
- K161090 — Cranial PSI
- K140309 — CRANIOPLUG
Data sourced from openFDA. This site is unofficial and independent of the FDA.