What is FDA product code ODP?

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Ayers Rock Cervical Interbody Fusion System · Intervertebral Fusion Device with Bone Graft, Cervical → Orthopedic

Name: Ayers Rock Cervical interbody fusion system
Brand: Ayers Rock Cervical interbody fusion system

7manufacturers in China registered for this device type

49catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ODP
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Zibo Dante Co., Ltd.	Zibo	Shandong	Contract manufacturer	17
Zhisu Health Tech Jiaxing Co., Ltd.	Tongxiang	Zhejiang	Contract manufacturer	4
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Zhejiang Decans Medical Devices Co., Ltd.	Jiaxing	Zhejiang	Manufacturer	10
Shanghai Sanyou Medical Co., Ltd.	Shanghai	Shanghai	Manufacturer	6

Record

Regulatory record for Ayers Rock Cervical interbody fusion system
Listed by	Spineway SA, France
FDA product code	ODP
Device type	Intervertebral Fusion Device With Bone Graft, Cervical
Device class	Class 2
Regulation	21 CFR 888.3080
Record published	2017-01-17
Record revised	2025-02-06 (version 4)

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, manufacturing date
Sizes	Height 5 to 10 mm; width 13 to 19 mm; length 12 to 15 mm
Distribution end date	2024-05-26

Catalogue Numbers

Catalogue numbers for Ayers Rock Cervical interbody fusion system
Catalogue number	Size	Status
1		Withdrawn
1	Height 6 mm	Withdrawn
2	Width 19 mm	Withdrawn
2	Height 8 mm	Withdrawn
1	S	Withdrawn
2	Width 19 mm	Withdrawn
2	Height 5 mm	Withdrawn
1	M	Withdrawn
2	Width 16 mm	Withdrawn
2	Width 13 mm	Withdrawn
1	Height 6 mm	Withdrawn
2	S	Withdrawn
2	S	Withdrawn
2	Height 9 mm	Withdrawn
1		Withdrawn
1	S	Withdrawn
1	M	Withdrawn
2	S	Withdrawn
1	L	Withdrawn
1	Height 7 mm	Withdrawn
1	L	Withdrawn
2	Height 5 mm	Withdrawn
2	Height 7 mm	Withdrawn
2		Withdrawn
1	L	Withdrawn
1	S	Withdrawn
2	Height 9 mm	Withdrawn
1	Height 5 mm	Withdrawn
2	Width 19 mm	Withdrawn
1	Height 10 mm	Withdrawn
2	Width 13 mm	Withdrawn
2	Height 10 mm	Withdrawn
2	Height 6 mm	Withdrawn
2	Width 19 mm	Withdrawn
1	Height 10 mm	Withdrawn
2	Height 7 mm	Withdrawn
2	Height 7 mm	Withdrawn
1		Withdrawn
1	Height 8 mm	Withdrawn
2	Height 10 mm	Withdrawn
2	Height 5 mm	Withdrawn
2	Width 16 mm	Withdrawn
2		Withdrawn
1	M	Withdrawn
1		Withdrawn
1	S	Withdrawn
2	Height 8 mm	Withdrawn
2		Withdrawn
1	Height 9 mm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Latitude-C AM™ Cervical Interbody Fusion System	Degen Medical	1,529
IdentiTi	Alphatec Spine, Inc.	1,390
Zavation	Zavation	1,357
IVA Cage Ti	Diomedical Co., Ltd.	1,202
Latitude-C Cervical Interbody Spacer System	Degen Medical	1,185
Peridot Anterior Cervical Intervertebral Body Fusion System	Gbs Commonwealth Co., Ltd.	1,056
Aleutian® Interbody Systems	VB Spine LLC	1,017
Valeo Spacer System	Sintx Technologies Inc.	918
Cascadia™ Interbody System	VB Spine LLC	823
CoRoent	Nuvasive, Inc.	815
Tyber Medical	Tyber Medical	740
Matisse Anterior Cervical Interbody Fusion Cage System	CTL Medical Corporation	577

Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K162694	2017-01-12

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.

Ayers Rock Cervical Interbody Fusion System