Orthopedic › ProstheticIntervertebral Fusion Device With Bone Graft, Lumbar

Zyston Straight Spacer SYS

70 catalogue numbers from 14-534254, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Bone Graft, Lumbar. 14 manufacturers in China are registered for this product code.

Registry build 21.09.26
14manufacturers in China registered for this device type
70catalogue numbers in this listing
5510(k) clearances naming this product code

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 Zyston Straight Spacer SYS
Listed by Biomet Spine, United States
FDA product code MAX
Device type Intervertebral Fusion Device With Bone Graft, Lumbar
Device class Class 2
Regulation 21 CFR 888.3080
Record published 2015-10-24
Record revised 2025-01-03 (version 5)

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

Catalogue Numbers

Catalogue numbers for Zyston Straight Spacer SYS
Catalogue number Size Status
14-534254 STR SPACER 14HX25LX10W X 8 DEG In distribution
14-534009 STR SPACER 9HX20LX10W CONVEX In distribution
14-534011 STR SPACER 11HX20LX10W CONVEX In distribution
14-534196 STR SPACER 16HX20LX10W X 8 DEG In distribution
14-534158 STR SPACER 18HX30LX11W CONVEX In distribution
14-534187 STR SPACER 7HX20LX10W X 8 DEG In distribution
14-534110 STR SPACER 10HX25LX12W CONVEX In distribution
14-534055 STR SPACER 15HX20LX12W CONVEX In distribution
14-534010 STR SPACER 10HX20LX10W CONVEX In distribution
14-534030 STR SPACER 10HX20LX11W CONVEX In distribution
14-534095 STR SPACER 15HX25LX11W CONVEX In distribution
14-534169 STR SPACER 9HX30LX12W CONVEX In distribution
14-534015 STR SPACER 15HX20LX10W CONVEX In distribution
14-534073 STR SPACER 13HX25LX10W CONVEX In distribution
14-534134 STR SPACER 14HX30LX10W CONVEX In distribution
14-534288 STR SPACER 8HX25LX12W X 8 DEG In distribution
14-534255 STR SPACER 15HX25LX10W X 8 DEG In distribution
14-534238 STR SPACER 18HX20LX12W X 8 DEG In distribution
14-534050 STR SPACER 10HX20LX12W CONVEX In distribution
14-534209 STR SPACER 9HX20LX11W X 8 DEG In distribution
14-534116 STR SPACER 16HX25LX12W CONVEX In distribution
14-534075 STR SPACER 15HX25LX10W CONVEX In distribution
14-534267 STR SPACER 7HX25LX11W X 8 DEG In distribution
14-534173 STR SPACER 13HX30LX12W CONVEX In distribution
14-534031 STR SPACER 11HX20LX11W CONVEX In distribution
14-534029 STR SPACER 9HX20LX11W CONVEX In distribution
14-534217 STR SPACER 17HX20LX11W X 8 DEG In distribution
14-534207 STR SPACER 7HX20LX11W X 8 DEG In distribution
14-534068 STR SPACER 8HX25LX10W CONVEX In distribution
14-534057 STR SPACER 17HX20LX12W CONVEX In distribution
14-534096 STR SPACER 16HX25LX11W CONVEX In distribution
14-534298 STR SPACER 18HX25LX12W X 8 DEG In distribution
14-534175 STR SPACER 15HX30LX12W CONVEX In distribution
14-534293 STR SPACER 13HX25LX12W X 8 DEG In distribution
14-534287 STR SPACER 7HX25LX12W X 8 DEG In distribution
14-534170 STR SPACER 10HX30LX12W CONVEX In distribution
14-534097 STR SPACER 17HX25LX11W CONVEX In distribution
14-534294 STR SPACER 14HX25LX12W X 8 DEG In distribution
14-534237 STR SPACER 17HX20LX12W X 8 DEG In distribution
14-534027 STR SPACER 7HX25LX11W CONVEX In distribution
14-534188 STR SPACER 8HX20LX10W X 8 DEG In distribution
14-534191 STR SPACER 11HX20LX10W X 8 DEG In distribution
14-534128 STR SPACER 8HX30LX10W CONVEX In distribution
14-534172 STR SPACER 12HX30LX12W CONVEX In distribution
14-534194 STR SPACER 14HX20LX10W X 8 DEG In distribution
14-534087 STR SPACER 7HX25LX11W CONVEX In distribution
14-534034 STR SPACER 14HX20LX11W CONVEX In distribution
14-534130 STR SPACER 10HX30LX10W CONVEX In distribution
14-534155 STR SPACER 15HX30LX11W CONVEX In distribution
14-534056 STR SPACER 16HX20LX12W CONVEX In distribution
14-534058 STR SPACER 18HX20LX12W CONVEX In distribution
14-534214 STR SPACER 14HX20LX11W X 8 DEG In distribution
14-534295 STR SPACER 15HX25LX12W X 8 DEG In distribution
14-534156 STR SPACER 16HX30LX11W CONVEX In distribution
14-534153 STR SPACER 13HX30LX11W CONVEX In distribution
14-534147 STR SPACER 7HX30LX11W CONVEX In distribution
14-534249 STR SPACER 9HX25LX10W X 8 DEG In distribution
14-534247 STR SPACER 7HX25LX10W X 8 DEG In distribution
14-534091 STR SPACER 11HX25LX11W CONVEX In distribution
14-534250 STR SPACER 10HX25LX10W X 8 DEG In distribution
14-534154 STR SPACER 14HX30LX11W CONVEX In distribution
14-534092 STR SPACER 12HX25LX11W CONVEX In distribution
14-534151 STR SPACER 11HX30LX11W CONVEX In distribution
14-534211 STR SPACER 11HX20LX11W X 8 DEG In distribution
14-534090 STR SPACER 10HX25LX11W CONVEX In distribution
14-534136 STR SPACER 16HX30LX10W CONVEX In distribution
14-534088 STR SPACER 8HX25LX11W CONVEX In distribution
14-534292 STR SPACER 12HX25LX12W X 8 DEG In distribution
14-534094 STR SPACER 14HX25LX11W CONVEX In distribution
14-534108 STR SPACER 8HX25LX12W CONVEX 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
K153695 2016-01-21
K151483 2015-07-31
K142634 2015-03-12
K112014 2011-10-17
K081636 2008-08-07

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer