FlexBand; FlexPatch; FlexBand Plus— 510(k) K230316
Substantially EquivalentInternational Life Sciences
FDA 510(k) clearance K230316 for FlexBand; FlexPatch; FlexBand Plus, Substantially Equivalent on 2023-05-26. Applicant: International Life Sciences. Device class: 2.
Clearance details
- Applicant
- International Life Sciences
- Product code
- Code OWW
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
Recent devices under product code OWW
view allMore clearances from International Life Sciences
view allRecalls naming K230316
K-number listed on FDA's recall record- Z-1554-2026 — Artelon FlexBand Dynamic Matrix Ref: 31057
- Z-1555-2026 — Artelon FlexBand Plus Ref: 41054 & 41057
- Z-1556-2026 — Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230316.
Data sourced from openFDA. This site is unofficial and independent of the FDA.