Who else makes this device?

Name: Cross-Fuse™* II Peek VBR/IBF System
Brand: Cross-Fuse™* II Peek VBR/IBF System

Cross-Fuse™* II Peek VBR/IBF System · Spinal Vertebral Body Replacement Device → Orthopedic

3manufacturers in China registered for this device type

116catalogue numbers in this listing

3510(k) clearances naming this product code

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 Cross-Fuse™* II Peek VBR/IBF System
Listed by	Pioneer Surgical Technology, Inc., United States
FDA product code	MQP
Device type	Spinal Vertebral Body Replacement Device
Device class	Class 2
Regulation	21 CFR 888.3060
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
Record published	2015-12-21
Record revised	2026-02-18 (version 8)

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
Distribution end date	2023-07-21

Catalogue Numbers

Catalogue numbers for Cross-Fuse™* II Peek VBR/IBF System
Catalogue number	Size	Status
38-2260-17		Withdrawn
38-1840-11		Withdrawn
38-1865-13		Withdrawn
38-2665-15-12L		Withdrawn
38-2250-13-6L		Withdrawn
38-2650-13-12L		Withdrawn
38-2265-15		Withdrawn
38-1455-15		Withdrawn
38-1865-9-6C		Withdrawn
38-2650-9-6L		Withdrawn
38-1860-15-6C		Withdrawn
38-2655-15-6L		Withdrawn
38-1855-17-6L		Withdrawn
38-1850-13-12L		Withdrawn
38-1860-15		Withdrawn
38-1860-13		Withdrawn
38-2650-15-12L		Withdrawn
38-2260-17-18L		Withdrawn
38-1850-11-6C		Withdrawn
38-1840-15-6L		Withdrawn
38-2260-13-18L		Withdrawn
38-1855-17		Withdrawn
38-2260-9		Withdrawn
38-2645-15		Withdrawn
38-1850-15-6L		Withdrawn
38-2260-7		Withdrawn
38-1865-15-6C		Withdrawn
38-2245-13		Withdrawn
38-2665-13-12L		Withdrawn
38-2270-9		Withdrawn
38-2250-7		Withdrawn
38-1855-11-6C		Withdrawn
38-2655-9		Withdrawn
38-2650-15		Withdrawn
38-1865-11-18L		Withdrawn
38-2655-13		Withdrawn
38-1860-15-6L		Withdrawn
38-1445-13		Withdrawn
38-2655-13-12L		Withdrawn
38-1840-7-6C		Withdrawn
38-1840-9		Withdrawn
38-1845-11		Withdrawn
38-2265-17-18L		Withdrawn
38-1855-13-6L		Withdrawn
38-1865-17		Withdrawn
38-2245-9		Withdrawn
38-1455-9		Withdrawn
38-1840-15-18L		Withdrawn
38-1860-15-12L		Withdrawn
38-1440-9-6L		Withdrawn
38-1860-11-6C		Withdrawn
38-2260-15-12L		Withdrawn
38-2660-15-12L		Withdrawn
38-2645-9-6L		Withdrawn
38-1850-9-12L		Withdrawn
38-1850-11		Withdrawn
38-1870-9		Withdrawn
38-2260-11		Withdrawn
38-1860-13-6C		Withdrawn
38-1870-15-6C		Withdrawn
38-1840-15		Withdrawn
38-1840-13-6L		Withdrawn
38-2250-13-12L		Withdrawn
38-2260-15-6L		Withdrawn
38-2265-9		Withdrawn
38-2660-11-12L		Withdrawn
38-2255-13-12L		Withdrawn
38-2645-13-12L		Withdrawn
38-2245-15-18L		Withdrawn
38-2250-15-6L		Withdrawn
38-2250-13-18L		Withdrawn
38-1435-7		Withdrawn
38-1845-13		Withdrawn
38-1440-9		Withdrawn
38-1845-9		Withdrawn
38-1855-17-6C		Withdrawn
38-1440-7		Withdrawn
38-2645-11-6L		Withdrawn
38-2660-13-12L		Withdrawn
38-2645-13-6L		Withdrawn
38-2260-13-12L		Withdrawn
38-2255-13-18L		Withdrawn
38-1850-13-6L		Withdrawn
38-2645-15-12L		Withdrawn
38-1855-9-6C		Withdrawn
38-2665-17-12L		Withdrawn
38-2645-7		Withdrawn
38-1450-13		Withdrawn
38-1865-13-6C		Withdrawn
38-1855-15-12L		Withdrawn
38-2650-13-6L		Withdrawn
38-2655-9-6L		Withdrawn
38-1445-9-6L		Withdrawn
38-2660-15-6L		Withdrawn
38-2255-17		Withdrawn
38-2245-15		Withdrawn
38-2645-9		Withdrawn
38-1860-9		Withdrawn
38-1855-13-18L		Withdrawn
38-2650-11-12L		Withdrawn
38-2260-17-6L		Withdrawn
38-1840-7		Withdrawn
38-2265-13		Withdrawn
38-2250-15		Withdrawn
38-2660-15		Withdrawn
38-2650-9		Withdrawn
38-2265-17		Withdrawn
38-1845-11-6C		Withdrawn
38-2265-13-18L		Withdrawn
38-2650-15-6L		Withdrawn
38-2260-9-6L		Withdrawn
38-2655-11-12L		Withdrawn
38-2250-11-12L		Withdrawn
38-1450-15-6L		Withdrawn
38-2245-13-12L		Withdrawn
38-2645-11		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K131724	2013-12-24
K061151	2006-07-24
K043206	2005-01-21

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.

Cross-Fuse™* II Peek VBR/IBF System