INION BIORESTORE— 510(k) K070784
Substantially EquivalentInion OY
FDA 510(k) clearance K070784 for INION BIORESTORE, Substantially Equivalent on 2007-07-24. Applicant: Inion OY. Device class: 2.
Clearance details
- Applicant
- Inion OY
- Product code
- Code LYC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampere, FI
Recent devices under product code LYC
view allMore clearances from Inion OY
view all- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
- K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- K203105 — Inion CompressOn Screw
- K191764 — Inion BioRestore
- K151360 — Inion Spinal Graft Containment System
Data sourced from openFDA. This site is unofficial and independent of the FDA.