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Panels › Orthopedic › Product code ODP · Class 2

Intervertebral Fusion Device With Bone Graft, Cervical

Regulation 888.3080

24510(k)s in 12 months (354 all time)
2recalls in 12 months (11 all time)
9recalls that name a 510(k)
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Top companies in ODP

DateFirm and productCodeLinked 510(k)
Dec 11, 2025Orthofix U.S. LLC
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordo
Open, Classified
ODPK203342
Dec 11, 2025Orthofix U.S. LLC
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parall
Open, Classified
ODPK172437
Aug 24, 2023Medicrea International
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; interve
Open, Classified
ODPNone listed
Aug 24, 2023Medicrea International
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
Open, Classified
ODPNone listed
Aug 24, 2023Medicrea International
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B201
Open, Classified
ODPK100484
Sep 30, 2020XTANT Medical
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR
Terminated
ODPK173832
Jan 3, 2014RTI Surgical, Inc.
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to pr
Terminated
ODPK073177
Aug 27, 2013SpineNet
SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc dise
Terminated
ODPK110733
Jul 31, 2012Exactech, Inc.
Octane-C Cervical, 6 Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Terminated
ODPK103655
Oct 21, 2011Synthes USA (HQ), Inc.
Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.
Terminated
ODPK072981
K093762
Jun 10, 2009Synthes Spine
Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
Terminated
ODPK072981

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