Aries-L Lateral Lumbar Interbody System
Model 1450-1242 · Osseus Fusion Systems, LLC · DI B06214501242
FZK — Chair, Surgical, Non-Electrical · Class I · 21 CFR 878.4950
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K181347 — cites (transitively): K072791 (d1), K082698 (d1), K090707 (d1), K091088 (d1), K101302 (d1), K150788 (d1), K160547 (d1), K162264 (d1), K170503 (d1), K172009 (d1), K172941 (d1), P950002 (d1), P950019 (d1), P960025 (d1), K110843 (d2), K130699 (d2), K150481 (d2), K160125 (d2), K080588 (d2), K092193 (d2), K093669 (d2), K112095 (d2), K122588 (d2), K143258 (d2), K141665 (d2), K123767 (d2), K131533 (d2), K131547 (d2), K133614 (d2), K051454 (d3), K063399 (d3), K080024 (d3), K080699 (d3), K102293 (d3), K031672 (d3), K103169 (d3), K091253 (d3), K972718 (d3), K071795 (d3), K090816 (d3), K113348 (d3), K120918 (d3), K123045 (d3), K123231 (d3), K130820 (d3), K131082 (d3), K132601 (d3), K133455 (d3), K140319 (d3), K103111 (d3), K112316 (d3), K100945 (d3), K113138 (d3), K113561 (d3), K141405 (d3), K072991 (d3), K133494 (d3), K150362 (d3), K152304 (d3), K080401 (d4), K072970 (d4), K093242 (d4), K073202 (d4), K083626 (d4), K081917 (d4), K083894 (d4), K031635 (d4), K080568 (d4), K101923 (d4), K080537 (d4), K023570 (d4), K062933 (d4), K073291 (d4), K082310 (d4), K091278 (d4), K100042 (d4), K130548 (d4), K043206 (d4), K133623 (d4), K073285 (d4), K092211 (d4), K120031 (d4), K122630 (d4), K110632 (d4), K122967 (d4), K071724 (d4), K081968 (d4), K100089 (d4), K131372 (d4), K081611 (d4), K140003 (d4), K140921 (d4), K142050 (d4), K142264 (d4), K060506 (d4), K123486 (d4), K132624 (d4), K143393 (d4), K143616 (d4), K043479 (d5), P970015 (d5), K073348 (d5), K062083 (d5), K072253 (d5), K083475 (d5), K080971 (d5), K092070 (d5), K072160 (d5), K092901 (d5), K090064 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K042993 (d5), K051146 (d5), K051380 (d5), K051977 (d5), K053514 (d5), K061521 (d5), K072221 (d5), K072575 (d5), K123166 (d5), K123206 (d5), K130177 (d5), K053340 (d5), K100391 (d5), K082262 (d6), K042871 (d6), K052888 (d6), K050539 (d6), K063423 (d6), K974556 (d6), P980048 (d6) — cited as predicate by K182987, K211474, K213935
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Osseus Fusion Systems, LLC
- NAI 2018-08-24 Osseus Fusion Systems, LLC · 0 citations
- NAI 2018-08-24 Osseus Fusion Systems, LLC · 0 citations
- VAI 2015-04-23 Osseus Fusion Systems, LLC · 0 citations
- VAI 2015-04-23 Osseus Fusion Systems, LLC · 0 citations