International Life Sciences
Sandy Springs, GA, US
INTERNATIONAL LIFE SCIENCES appears in FDA device records in Sandy Springs, GA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for International Life Sciences between 2019 and 2026. The busiest year on record is 2019, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260317 | Artelon Convenience Kits | QWJ | Substantially Equivalent | |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | OWW | Substantially Equivalent | |
| K200503 | ATL Anchors | MBI | Substantially Equivalent | |
| K192112 | FlexBand Plus | FTL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010673515 | 3010673515 | INTERNATIONAL LIFE SCIENCES | 8601 Dunwoody Pl #250, Sandy Springs, GA 30350 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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) | Augmentation devices failed bacterial endotoxin testing. | Class II | Open, Classified | |
| Z-1555-2026 | Artelon FlexBand Plus Ref: 41054 & 41057 | Augmentation devices failed bacterial endotoxin testing. | Class II | Open, Classified | |
| Z-1554-2026 | Artelon FlexBand Dynamic Matrix Ref: 31057 | Augmentation devices failed bacterial endotoxin testing. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain