Atlas FDA

FlexBand; FlexPatch; FlexBand Plus

FDA 510(k) clearance K230316 · decided 2023-05-26

Clearance details

K-number
K230316
Device name
FlexBand; FlexPatch; FlexBand Plus
Applicant
International Life Sciences
Decision
Substantially Equivalent
Date received
2023-02-06
Decision date
2023-05-26
Days to decision
109 days
Clearance type
Traditional
Product code
OWW
Device class
2
Regulation number
878.3300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Marietta, GA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Artelon FlexBand Dynamic Matrix Ref: 31057 recall (Z-1554-2026)International Life Sciences2026-03-11
Artelon FlexBand Plus Ref: 41054 & 41057 recall (Z-1555-2026)International Life Sciences2026-03-11
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qt recall (Z-1556-2026)International Life Sciences2026-03-11