ATL Anchors
FDA 510(k) clearance K200503 · decided 2020-09-02
Clearance details
- K-number
- K200503
- Device name
- ATL Anchors
- Applicant
- International Life Sciences
- Decision
- Substantially Equivalent
- Date received
- 2020-03-02
- Decision date
- 2020-09-02
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Artelon FlexBand Dynamic Matrix Ref: 31057 recall (Z-1554-2026) | International Life Sciences | 2026-03-11 |
| Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qt recall (Z-1556-2026) | International Life Sciences | 2026-03-11 |