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INTEGRATE-C

Model Trial - Small 15 x 12 x 7/8 mm, 10 deg · Happe Spine, LLC · DI G2308HT0708S100

LYQ — Accessories, Fixation, Spinal Intervertebral Body · Class I · 21 CFR 888.4540

UDILibrary device dossier · generated 2026-09-12 · 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.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2022-05	0	1
2025-01	0	1

This device (reports/month)Average device in LYQ (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K222004 — cites (transitively): K133784 (d1), K172484 (d1), K173030 (d1), K191581 (d1), K070382 (d2), K142026 (d2), K151198 (d2), K143685 (d2), K163491 (d2), K073109 (d2), K080615 (d2), K140055 (d2), K142589 (d2), K163269 (d2), K170399 (d2), K173535 (d2), K183557 (d2), K192018 (d2), K102067 (d3), K090064 (d3), K110733 (d3), K113518 (d3), K032812 (d3), K083714 (d3), K100889 (d3), K111626 (d3), K133218 (d3), K102547 (d3), K131880 (d3), K123045 (d3), K141953 (d3), K150362 (d3), K150481 (d3), K160125 (d3), P950019 (d3), P960025 (d3), K148529 (d3), K151596 (d3), K153122 (d3), K170676 (d3), K171686 (d3), K172676 (d3), K180364 (d3), K190959 (d3), K082801 (d4), P980048 (d4), P950002 (d4), K073351 (d4), K082260 (d4), K071795 (d4), K091088 (d4), K071833 (d4), K112036 (d4), K122771 (d4), K081611 (d4), K140003 (d4), K140921 (d4), K142050 (d4), K142264 (d4), K082698 (d4), K100945 (d4), K110843 (d4), K112316 (d4), K113138 (d4), K113561 (d4), K130699 (d4), K133614 (d4), K141405 (d4), K142940 (d4), K072991 (d4), K103169 (d4), K133494 (d4), K152304 (d4), K072253 (d4), K072791 (d4), K160547 (d4), K120570 (d4), K153107 (d4), K162103 (d4), K120603 (d4), K162138 (d4), K163230 (d4), K120275 (d4), K162264 (d4), K171496 (d4), K171689 (d4), K080401 (d5), K081917 (d5), K101302 (d5), K051454 (d5), K063399 (d5), K080024 (d5), K080699 (d5), K083626 (d5), K083894 (d5), K073202 (d5), K073285 (d5), K100214 (d5), K050553 (d5), K072465 (d5), K091426 (d5), K111123 (d5), K083389 (d5), K031672 (d5), K092211 (d5), K120031 (d5), K122630 (d5), K123206 (d5), K071724 (d5), K081968 (d5), K100089 (d5), K131372 (d5), K130177 (d5), K072415 (d5), K113252 (d5), K113559 (d5), K120819 (d5), K060506 (d5), K123486 (d5), K132624 (d5), K143393 (d5), K143616 (d5), K073669 (d5), K100210 (d5), K120991 (d5), K123997 (d5), K140142 (d5), K143740 (d5), K153495 (d5), K140319 (d5), K160916 (d5), K141665 (d5), K161230 (d5), K101171 (d5), K142251 (d5), K152532 (d5), K160924 (d5), K162262 (d5), K073291 (d5), K094025 (d5), K121332 (d5), K121333 (d5), K122037 (d5), K123027 (d5), K133205 (d5), K151128 (d5), K162358 (d5), K052261 (d6), K073177 (d6), K090425 (d6), K092336 (d6), P000028 (d6), K094042 (d6), K062083 (d6), K083475 (d6), K030327 (d6), K083026 (d6), K091813 (d6), K080971 (d6), K092070 (d6), K082732 (d6), K043479 (d6), K072160 (d6), K031729 (d6), K040267 (d6), K042883 (d6), K042993 (d6), K051146 (d6), K051380 (d6), K051977 (d6), K053514 (d6), K061521 (d6), K072221 (d6), K072575 (d6), K123166 (d6), K062151 (d6), K110632 (d6), K113348 (d6), K122967 (d6), K132601 (d6), K090816 (d6), K120918 (d6), K123231 (d6), K130820 (d6), K131082 (d6), K133455 (d6), K120486 (d6), K053340 (d6), K100391 (d6), K133577 (d6), K133650 (d6), K072981 (d6), K102606 (d6), K133328 (d6), K142066 (d6), K150053 (d6), K082262 (d6), K090507 (d6), K110327 (d6), K113285 (d6), K142645 (d6), K150643 (d6), K152475 (d6), K153782 (d6), K150788 (d6), K151310 (d6), K151322 (d6), K141896 (d6), K153419 (d6), K160051 (d6), K151726 (d6), K160955 (d6), K150673 (d6), K151276 (d6), K151773 (d6), K042871 (d7), K052888 (d7), K073348 (d7), K103382 (d7), K031635 (d7), K080568 (d7), K101923 (d7), K050539 (d7), K063423 (d7), K974556 (d7), K080537 (d7), K023570 (d7), K062933 (d7), K082310 (d7), K091278 (d7), K092193 (d7), K100042 (d7), K130548 (d7), K043206 (d7), K133623 (d7), K100175 (d7), K112405 (d7), K113528 (d7), K122591 (d7), K132897 (d7), K121760 (d7), K140659 (d7), K082014 (d7), K120869 (d7), K131276 (d7), K101301 (d7), K141942 (d7), K121982 (d7), K122639 (d7), K080281 (d7), K081614 (d7), K122989 (d7), K132700 (d7), K151472 (d7), K143163 (d7), K140759 (d7), K103111 (d7), K121649 (d7), K150994 (d7), K100043 (d7), K131723 (d7), K140479 (d7), P970015 (d8), K082252 (d8), K093242 (d8), K090353 (d8), K073470 (d8), K101812 (d8), K120368 (d8), K040482 (d8), K040928 (d8), K082406 (d8), K090899 (d8), K092574 (d8), K092901 (d8), K001340 (d8), K023835 (d8), K030833 (d8), K052746 (d8), K073649 (d8), K082128 (d8), K110454 (d8), K110694 (d8), K101310 (d8), K102090 (d8), K111122 (d8), K133200 (d8), K133286 (d8), K083661 (d8), K093704 (d8), K093864 (d8), K100865 (d8), K101051 (d8), K141217 (d8) — cited as predicate by K232150, K241396

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Happe Spine, LLC

VAI 2025-05-08 HAPPE SPINE, LLC. · 2 citations
VAI 2025-05-08 HAPPE SPINE, LLC. · 2 citations