510(k) K242827

Device: A8 INTEGR8 Porous Pedicle Screws
Applicant: Allumin8, Inc.
510(k) number: K242827
Product code: NKB
Decision: Substantially Equivalent (SESE)
Decision date: 2025-10-20
Date received: 2024-09-18
Regulation: 888.3070
Classification name: Thoracolumbosacral Pedicle Screw System
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N
Source: FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact: Alyssa Huffman
Address: 3158 W. Lakefront Ct. Springfield MO US 65810 65810

FDA Registration Numbers

1450662
3021006165
3010128826
3015487912
3014252644
3001239363
3004464325
2183744
3023852420
1834331
3003541440
3013756169
3013194153
3009962553
1833824
3009504230
3000170817
1319660
3008754074
3014268622
3021945817
3007700286
1045254
3012429289
9612277
3010863450
3019767615
1531050
3006128100
3019837678
1225838
1030489
3029933740
3004719693
1649379
2183449
3039169546
3004024955
9617616
3012120772
3010365473
3005083075
3009887475
3022518322
3023138345
1221053
3010047454
3013546462
9615014
3009973505
3009554293
2087234
2032112
3012447612
3012599928
9616062
9611827
3011513267
1530390
2531195
3006017180
1835296
3007887127
2029275
9615128
3004049923
3008992889
3010531060
3004893332
3009988302
1528646
1722511
3011181154
3005226664
3016084569
3009165919
3011277306
3003526896
3019356409
8010468

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DI	Brand	Company	Published
00850062071346	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071001	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071209	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071216	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071223	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071230	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071247	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071254	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071261	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071278	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071285	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071292	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071308	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071315	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071322	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071339	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071490	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071353	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071360	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071377	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071384	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071391	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071407	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071414	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071421	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071438	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071445	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071452	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071469	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27
00850062071476	A8 INTEGR8® Porous Pedicle Screw System	ALLUMIN8, INC.	2026-02-27

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K252542	LEO Spinal System	ZheJiang Decans Medical Devices Co., Ltd.	2026-04-29
K253940	M.U.S.T. Pedicle Screw System - Extension	Medacta International S.A.	2026-04-28
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K254274	ARx® SAI Implant System	Life Spine, Inc.	2026-04-16
K260786	KHEIRON® Spinal Fixation System, including patient specific K-ROD	S.M.A.I.O	2026-04-03
K254247	OSTEOMNI SPINAL FIXATION SYSTEM	Osteomni, Inc.	2026-02-24
K253169	Duet Spinal Fixation System	Box Spine, LLC	2026-02-23
K253545	Vulcan Spinal System	K2m, Inc.	2026-02-10
K252461	Swedge Pedicle Screw Fixation System Bezier Rod	Spinal Resources, Inc.	2026-01-13
K253990	KHEIRON® Spinal Fixation System, including patient specific K-ROD	S.M.A.I.O	2026-01-07
K253941	CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)	Medtronic Sofamor Danek USA, Inc.	2026-01-07