Leopard

LEOPARD VBR SPINAL SYSTEM CURVED, LORDOTIC 5 DEGREES, 28 x 11mm

Registry build 21.09.26
3manufacturers in China registered for this device type
37catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MQP
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53

Record

Regulatory record for Leopard
Listed by Medos International Sàrl, Switzerland
FDA product code MQP
Device type Spinal Vertebral Body Replacement Device
Device class Class 2
Regulation 21 CFR 888.3060
510(k) K031635
Record published 2015-09-24
Record revised 2020-02-24 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2019-04-30

Catalogue Numbers

Catalogue numbers for Leopard
Catalogue number Size Status
186448018 Withdrawn
186448016 Withdrawn
186449007 Withdrawn
186448009 Withdrawn
186448007 Withdrawn
186448110 Withdrawn
186448107 Withdrawn
186448112 Withdrawn
186448118 Withdrawn
186449112 Withdrawn
186449008 Withdrawn
186449111 Withdrawn
186449107 Withdrawn
186449109 Withdrawn
186449011 Withdrawn
186449108 Withdrawn
186448014 Withdrawn
186448017 Withdrawn
186449012 Withdrawn
186449010 Withdrawn
186448011 Withdrawn
186448111 Withdrawn
186449009 Withdrawn
186448108 Withdrawn
186448116 Withdrawn
186448013 Withdrawn
186449013 Withdrawn
186449110 Withdrawn
186448113 Withdrawn
186448012 Withdrawn
186449114 Withdrawn
186448109 Withdrawn
186449113 Withdrawn
186448114 Withdrawn
186448015 Withdrawn
186448008 Withdrawn
186448010 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CoRoent Nuvasive, Inc. 1,514
Capri™ Corpectomy Cage System VB Spine LLC 1,509
Aleutian® Interbody Systems VB Spine LLC 1,189
Fortify Globus Medical, Inc. 866
Matrixx System Nexxt Spine LLC 748
Ascend Alphatec Spine, Inc. 555
Zavation VBR Trial Zavation 548
Verte-Stack® Spinal System Medtronic Sofamor Danek, Inc. 484
Timberline® Lateral Interbody Fusion System Biomet Spine 470
Timberline Lateral Fusion System Biomet Spine 459
Novel Alphatec Spine, Inc. 447
Hawkeye™ Vertebral Body Replacement (VBR) Choice Spine, LP 368

Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device

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