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.

Neowave LS · Intervertebral Fusion Device with Bone Graft, Lumbar → Orthopedic

Name: neoWave LS
Brand: neoWave LS

14manufacturers in China registered for this device type

73catalogue numbers in this listing

1510(k) clearance

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 neoWave LS
Listed by	Xenix Medical, 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, Complaint-file establishment, Manufacturer
510(k)	K182210
Record published	2020-11-23
Record revised	2025-07-18 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for neoWave LS
Catalogue number	Size	Status
23-LCN-2206		In distribution
23-LCX-2210		In distribution
23-LCT-2512		In distribution
23-LCT-2813		In distribution
23-LCX-2811		In distribution
23-LCX-2213		In distribution
23-LCT-2217		In distribution
23-LCN-2506		In distribution
23-LCT-2814		In distribution
23-LCT-2212		In distribution
23-LCX-2512		In distribution
23-LCT-2515		In distribution
23-LCT-2514		In distribution
23-LTT-2511		In distribution
23-LCT-2511		In distribution
23-LCT-2517		In distribution
23-LCT-2815		In distribution
23-LCT-2216		In distribution
23-LCX-2812		In distribution
23-LCT-2209		In distribution
23-LCT-2516		In distribution
23-LCT-2811		In distribution
23-LCX-2813		In distribution
23-LCT-2207		In distribution
23-LCT-2810		In distribution
23-LCT-2210		In distribution
23-LTT-2512		In distribution
23-LCT-2812		In distribution
23-LCX-2513		In distribution
23-LCT-2816		In distribution
23-LCX-2814		In distribution
23-LCX-2517		In distribution
23-LCX-2211		In distribution
23-LCT-2513		In distribution
23-LTT-2508		In distribution
23-LTT-2513		In distribution
23-LCT-2817		In distribution
23-LTT-2509		In distribution
23-LCX-2817		In distribution
23-LCX-2511		In distribution
23-LTT-2514		In distribution
23-LCX-2815		In distribution
23-LCX-2509		In distribution
23-LCX-2515		In distribution
23-LCT-2215		In distribution
23-LCX-2215		In distribution
23-LCX-2816		In distribution
23-LTT-2507		In distribution
23-LCN-2006		In distribution
23-LCT-2509		In distribution
23-LCT-2510		In distribution
23-LCX-2810		In distribution
23-LCN-2806		In distribution
23-LCX-2514		In distribution
23-LTT-2515		In distribution
23-LCT-2208		In distribution
23-LCT-2211		In distribution
23-LCX-2516		In distribution
23-LTT-2516		In distribution
23-LCT-2809		In distribution
23-LCX-2217		In distribution
23-LCT-2213		In distribution
23-LCT-2507		In distribution
23-LCX-2216		In distribution
23-LCT-2214		In distribution
23-LCN-3006		In distribution
23-LCX-2212		In distribution
23-LCT-2508		In distribution
23-LCX-2510		In distribution
23-LCT-2808		In distribution
23-LCX-2214		In distribution
23-LTT-2510		In distribution
23-LCX-2209		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
K253583	2026-02-23

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.

Neowave LS