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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K221535

Align Lumbar Interbody Fusion System · Acuity Surgical Devices, LLC · decided 2022-07-22 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Align 16-22551107-SPACUITY SURGICAL DEVICES, LLCOVD00810043486590
Align 16-22451507ACUITY SURGICAL DEVICES, LLCOVD00810043486064
Align 14-32211320-SPACUITY SURGICAL DEVICES, LLCOVD00810043484930
Align 16-18450707ACUITY SURGICAL DEVICES, LLCOVD00810043482943
Align 16-22451312ACUITY SURGICAL DEVICES, LLCOVD00810043486040
Align 14-38301307-SPACUITY SURGICAL DEVICES, LLCOVD00810043485425
Align 14-32211312-SPACUITY SURGICAL DEVICES, LLCOVD00810043484916
Align 16-18451307-SPACUITY SURGICAL DEVICES, LLCOVD00810043483926
Align 16-18551312ACUITY SURGICAL DEVICES, LLCOVD00810043483520
Align 14-36261507-SPACUITY SURGICAL DEVICES, LLCOVD00810043484817
Align 16-18551012-SPACUITY SURGICAL DEVICES, LLCOVD00810043484190
Align 16-18451512-SPACUITY SURGICAL DEVICES, LLCOVD00810043483957
Align 16-18451307ACUITY SURGICAL DEVICES, LLCOVD00810043482998
Align 16-18501207-SPACUITY SURGICAL DEVICES, LLCOVD00810043487184
Align 16-22601112ACUITY SURGICAL DEVICES, LLCOVD00810043486903
Align 16-22450807ACUITY SURGICAL DEVICES, LLCOVD00810043485869
Align 16-22600907ACUITY SURGICAL DEVICES, LLCOVD00810043486804
Align 16-22451107ACUITY SURGICAL DEVICES, LLCOVD00810043485982
Align 16-18450907ACUITY SURGICAL DEVICES, LLCOVD00810043482967
Align 14-38301107-SPACUITY SURGICAL DEVICES, LLCOVD00810043485395
Align 16-18501507-SPACUITY SURGICAL DEVICES, LLCOVD00810043484091
Align 16-18551012ACUITY SURGICAL DEVICES, LLCOVD00810043483506
Align 16-22501112-SPACUITY SURGICAL DEVICES, LLCOVD00810043486316
Align 16-22551012-SPACUITY SURGICAL DEVICES, LLCOVD00810043486576
Align 16-18501007-SPACUITY SURGICAL DEVICES, LLCOVD00810043484039