510(k) K230316 ยท OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
FlexBand; FlexPatch; FlexBand Plus
| Applicant | International Life Sciences, Marietta GA, US |
| Decision | Substantially Equivalent, May 26, 2023 |
| Received | Feb 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230316
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2026 | International Life Sciences Artelon FlexBand Dynamic Matrix
Ref: 31057 Open, Classified |
OWW | None listed |
| Mar 11, 2026 | International Life Sciences Artelon FlexBand Plus
Ref: 41054 & 41057 Open, Classified |
OWW | None listed |
| Mar 11, 2026 | International Life Sciences Artelon FLEXBAND TWIST .12
Ref: TW012
3.85x17mm HEX Anchor (Qty 2)
5.0x17mm HEX Anchor (Qty 1)
0.5x12cm FLEXBAND (Qty 1) Open, Classified |
OWW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.