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)
Top companies in ODP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Orthofix 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 |
ODP | K203342 |
| Dec 11, 2025 | Orthofix 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 |
ODP | K172437 |
| Aug 24, 2023 | Medicrea 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 |
ODP | None listed |
| Aug 24, 2023 | Medicrea 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 |
ODP | None listed |
| Aug 24, 2023 | Medicrea 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 |
ODP | K100484 |
| Sep 30, 2020 | XTANT 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 |
ODP | K173832 |
| Jan 3, 2014 | RTI 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 |
ODP | K073177 |
| Aug 27, 2013 | SpineNet 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 |
ODP | K110733 |
| Jul 31, 2012 | Exactech, Inc. Octane-C Cervical, 6 Lordotic
Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7). Terminated |
ODP | K103655 |
| Oct 21, 2011 | Synthes USA (HQ), Inc. Synthes Spine Zero-P Instruments and Implants.
Zero-profile anterior cervical interbody fusion (ACIF) device. Terminated |
ODP | K072981 K093762 |
| Jun 10, 2009 | Synthes 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 |
ODP | K072981 |
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