What is FDA product code OVD?

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Orthopedic › ProstheticIntervertebral Fusion Device With Integrated Fixation, Lumbar

37mm W X 28mm D X 18mm H, 20°, Pillar SA Ti, Sterile

Name: 37mm W X 28mm D X 18mm H, 20°, Pillar SA Ti, Sterile
Brand: 37mm W X 28mm D X 18mm H, 20°, Pillar SA Ti, Sterile

Catalogue number 82-3713SP, listed by Orthofix US LLC, United States, under Intervertebral Fusion Device With Integrated Fixation, Lumbar. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1recall

Who Else Makes It

Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVD
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
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53

Record

Regulatory record for 37mm W X 28mm D X 18mm H, 20°, Pillar SA Ti, Sterile
Listed by	Orthofix US LLC, United States
FDA product code	OVD
Device type	Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class	Class 2
Regulation	21 CFR 888.3080
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K240749
Record published	2025-07-17
Record revised	2026-02-20 (version 2)

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, manufacturing date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for 37mm W X 28mm D X 18mm H, 20°, Pillar SA Ti, Sterile
Catalogue number	Size	Status
82-3713SP		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sirion	Astura Medical	1,465
IdentiTi	Alphatec Spine, Inc.	1,372
EL Capitan	Astura Medical	1,205
Zavation	Zavation	1,157
Brigade	Nuvasive, Inc.	1,005
Solar™ Interbody Fusion System	Degen Medical	899
Zavation F3D Corpectomy	Zavation	730
ROI-A	Ldr Spine USA	552
Avenue L	Ldr Spine USA	524
Transcend Nanotec	Alphatec Spine, Inc.	485
Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology	Titan Spine, LLC	462
Base	Nuvasive, Inc.	462

Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of 37mm W X 28mm D X 18mm H, 20°, Pillar SA Ti, Sterile
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Orthofix US LLC	510(k) number	2025-06-24	Class II	Labeling design	A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.	3
Orthofix US LLC	510(k) number	2025-02-20	Class II	Labeling Change Control	The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.	20

Recalls

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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
2025-11-03	Class III	Device Design	Labeling contains claims that are not consistently present.	13317

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.