Who else makes this device?

Name: Stature®
Brand: Stature®

Stature® · Spinal Vertebral Body Replacement Device → Orthopedic

3manufacturers in China registered for this device type

5catalogue numbers in this listing

4510(k) clearances naming this product code

1recall

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 Stature®
Listed by	Atlas Spine Inc., United States
FDA product code	MQP
Device type	Spinal Vertebral Body Replacement Device
Device class	Class 2
Regulation	21 CFR 888.3060
Establishment	Manufacturer
Record published	2015-09-01
Record revised	2020-08-26 (version 5)

Specifications

Specifications
MRI safety	MR Conditional
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date
Sizes	Height 9 to 15 mm

Catalogue Numbers

Catalogue numbers for Stature®
Catalogue number	Size	Status
STL-013-010	Height 13 mm	In distribution
STF-015-012	Height 15 mm	In distribution
STF-011-008	Height 11 mm	In distribution
STL-017-014	Height 14 mm	In distribution
STL-009-006	Height 9 mm	In distribution

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
K091406	2009-09-04
K071497	2007-06-29
K063464	2007-03-09
K063205	2007-02-26

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
2013-07-26	Class II	Device Design	The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.	16	2019-07-26

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.

Stature®