What is FDA product code MAX?

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Abacus® Spacer System · Intervertebral Fusion Device with Bone Graft, Lumbar → Orthopedic

Name: Abacus® Spacer System
Brand: Abacus® Spacer System

Abacus Spacer System is a lumbar interbody fusion implant range made from PEEK with tantalum markers. A spacer fits between vertebral bodies, with an internal cavity for autogenous bone graft.

The rectangular body has a textured tooth pattern on its upper and lower surfaces. Those surfaces help resist migration after placement, while the markers provide a radiographic reference for the polymer implant.

Listed Item

Lordotic Implant 45x22x12mm 10deg

Fusion Assembly

The range includes different shapes and sizes to accommodate anatomy. Abacus is used with supplemental fixation for one or two contiguous levels from L2 through L5, combining the spacer, bone graft and stabilization hardware within the fusion construct.

14manufacturers in China registered for this device type

72catalogue numbers in this listing

14510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MAX
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	17
Zibo Dante Co., Ltd.	Zibo	Shandong	Contract manufacturer	17
Jiangsu Ideal Medical Science & Technology Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	7
Zhisu Health Tech Jiaxing Co., Ltd.	Tongxiang	Zhejiang	Contract manufacturer	4
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Shanghai Reach Medical Instrument Co., Ltd.	Shanghai	Shanghai	Manufacturer	30
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	25
Double Medical Technology Inc.	Xiamen	Fujian	Contract manufacturer	14
Zhejiang Decans Medical Devices Co., Ltd.	Jiaxing	Zhejiang	Manufacturer	10

Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar

Record

Regulatory record for Abacus® Spacer System
Listed by	Spine Wave, Inc., United States
FDA product code	MAX
Device type	Intervertebral Fusion Device With Bone Graft, Lumbar
Device class	Class 2
Regulation	21 CFR 888.3080
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K140007
Record published	2015-10-24
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Sizes	Width 18 to 22 mm; height 8 to 14 mm; length 40 to 60 mm; angle 10 °

Catalogue Numbers

Catalogue numbers for Abacus® Spacer System
Catalogue number	Size	Status
11-9092	Width 22 mm	In distribution
11-9031	Width 18 mm	In distribution
11-9030	Height 8 mm	In distribution
11-9026	Width 18 mm	In distribution
11-9070	Length 50 mm	In distribution
11-9083	Height 14 mm	In distribution
11-9022	Height 12 mm	In distribution
11-9013	Length 40 mm	In distribution
11-9106	Angle 10 °	In distribution
11-9036	Width 18 mm	In distribution
11-9037	Length 40 mm	In distribution
11-9057	Angle 10 °	In distribution
11-9016	Length 45 mm	In distribution
11-9080	Length 60 mm	In distribution
11-9073	Height 14 mm	In distribution
11-9048	Width 18 mm	In distribution
11-9023	Length 50 mm	In distribution
11-9058	Width 18 mm	In distribution
11-9042	Length 45 mm	In distribution
11-9065	Length 45 mm	In distribution
11-9075	Length 55 mm	In distribution
11-9093	Angle 10 °	In distribution
11-9021	Length 50 mm	In distribution
11-9096	Angle 10 °	In distribution
11-9051	Width 18 mm	In distribution
11-9047	Length 50 mm	In distribution
11-9038	Width 18 mm	In distribution
11-9072	Length 50 mm	In distribution
11-9045	Length 50 mm	In distribution
11-9081	Height 10 mm	In distribution
11-9041	Width 18 mm	In distribution
11-9018	Length 45 mm	In distribution
11-9053	Width 18 mm	In distribution
11-9052	Angle 10 °	In distribution
11-9082	Length 60 mm	In distribution
11-9105	Width 22 mm	In distribution
11-9050	Angle 10 °	In distribution
11-9108	Angle 10 °	In distribution
11-9097	Width 22 mm	In distribution
11-9078	Height 14 mm	In distribution
11-9010	Length 40 mm	In distribution
11-9055	Angle 10 °	In distribution
11-9011	Height 10 mm	In distribution
11-9020	Height 8 mm	In distribution
11-9017	Height 12 mm	In distribution
11-9067	Length 45 mm	In distribution
11-9046	Width 18 mm	In distribution
11-9040	Length 45 mm	In distribution
11-9025	Height 8 mm	In distribution
11-9071	Height 10 mm	In distribution
11-9015	Height 8 mm	In distribution
11-9091	Angle 10 °	In distribution
11-9035	Angle 10 °	In distribution
11-9077	Length 55 mm	In distribution
11-9101	Angle 10 °	In distribution
11-9100	Width 22 mm	In distribution
11-9066	Height 10 mm	In distribution
11-9028	Width 18 mm	In distribution
11-9090	Width 22 mm	In distribution
11-9043	Width 18 mm	In distribution
11-9068	Height 14 mm	In distribution
11-9095	Width 22 mm	In distribution
11-9107	Width 22 mm	In distribution
11-9098	Angle 10 °	In distribution
11-9032	Length 60 mm	In distribution
11-9027	Height 12 mm	In distribution
11-9012	Length 40 mm	In distribution
11-9056	Width 18 mm	In distribution
11-9076	Height 10 mm	In distribution
11-9103	Angle 10 °	In distribution
11-9102	Width 22 mm	In distribution
11-9033	Width 18 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Peridot Intervertebral body fusion system	Gbs Commonwealth Co., Ltd.	10,850
Yellowstone	Summit Spine	6,654
CoRoent	Nuvasive, Inc.	5,690
Zavation	Zavation	2,554
Anyplus II Spinal Fixation System	GS Medical Co., Ltd.	2,533
Talos® IBF	Meditech Spine, LLC	2,163
Peridot-PT Intervertebral body fusion system	Gbs Commonwealth Co., Ltd.	1,956
TirboLOX-L Lumbar Ibfd	Captiva Spine, Inc.	1,926
Endoskeleton® TL	Titan Spine, LLC	1,896
Evos Lumbar Interbody System	Cutting Edge Spine	1,871
Epiphany	Pantheon Spinal LLC	1,507
LnK Lumbar Interbody Fusion Cage System	L&K Biomed Co., Ltd.	1,506

Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K261159	2026-05-29
K243816	2025-06-27
K231275	2023-07-25
K163246	2017-04-06
K153222	2016-04-15
K152620	2016-01-15
K151581	2015-07-09
K150285	2015-03-05
K141980	2015-01-26
K142101	2014-10-23
K140007	2014-04-07
K132719	2013-10-04
K131071	2013-08-20
K123461	2013-04-11

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2013-05-14	Class II	Component change control	A component Superior endplate manufactured from a different polymer than specified	17 units	2014-02-10

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P000028	2004-06-18	AFFINITY ANTERIOR CERVICAL CAGE SYSTEM	Medtronic Sofamor Danek USA, Inc.
P970015	2003-09-10	LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE	Sofamor Danek
P980048	2001-04-20	BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM	Sulzer Spine-Tech
P950019	1999-03-19	RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION	Stryker Spine
P950002	1997-06-30	BAK INTERBODY FUSION SYSTEM	Zimmer Spine, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Abacus® Spacer System