ATL Anchors— 510(k) K200503
Substantially EquivalentInternational Life Sciences
FDA 510(k) clearance K200503 for ATL Anchors, Substantially Equivalent on 2020-09-02. Applicant: International Life Sciences. Device class: 2.
Clearance details
- Applicant
- International Life Sciences
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
Recent devices under product code MBI
view allMore clearances from International Life Sciences
view allAdverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
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 K200503
K-number listed on FDA's recall record- Z-1554-2026 — Artelon FlexBand Dynamic Matrix Ref: 31057
- 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 K200503.
Data sourced from openFDA. This site is unofficial and independent of the FDA.