ClearanceBrief
Panels › Orthopedic › Product code OVD · Class 2

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Regulation 888.3080

9510(k)s in 12 months (205 all time)
2recalls in 12 months (36 all time)
36recalls that name a 510(k)
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Top companies in OVD

DateFirm and productCodeLinked 510(k)
May 20, 2026Novapproach Spine, LLC
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree
Open, Classified
OVDK211769
Dec 11, 2025Orthofix U.S. LLC
Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39
Open, Classified
OVDK172437
Sep 11, 2025Omnia Medical
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Open, Classified
OVDK203207
Sep 11, 2025Omnia Medical
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Open, Classified
OVDK203207
Mar 31, 2025Stryker Spine
Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Open, Classified
OVDK201585
Mar 31, 2025Stryker Spine
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Open, Classified
OVDK201585
Mar 31, 2025Stryker Spine
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Open, Classified
OVDK201585
Mar 31, 2025Stryker Spine
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Open, Classified
OVDK201585
Feb 19, 2025XTANT Medical Holdings, Inc
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE))
Open, Classified
OVDK171567
Feb 23, 2024Alphatec Spine, Inc.
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / I
Open, Classified
OVDK232097
Aug 24, 2023Medicrea International
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
Open, Classified
OVDK141187
Jul 10, 2023Medtronic Sofamor Danek USA Inc
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Open, Classified
OVDK212653
Jul 10, 2023Medtronic Sofamor Danek USA Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
Open, Classified
OVDK212653
Jul 10, 2023Medtronic Sofamor Danek USA Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Open, Classified
OVDK212653
Jul 10, 2023Medtronic Sofamor Danek USA Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
Open, Classified
OVDK212653
Jul 10, 2023Medtronic Sofamor Danek USA Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Open, Classified
OVDK212653
Jul 10, 2023Medtronic Sofamor Danek USA Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
Open, Classified
OVDK212653
Jul 10, 2023Medtronic Sofamor Danek USA Inc
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Open, Classified
OVDK212653
Apr 24, 2023SPINEART SA
JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 0
Open, Classified
OVDK190877
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Completed
OVDK221545
Nov 17, 2022Novapproach Spine LLC
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
Terminated
OVDK211769
Sep 2, 2021Medtronic Sofamor Danek USA Inc
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Terminated
OVDK141953
K173535 +2
Jan 7, 2019Acuity Surgical Devices, LLC
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x1
Open, Classified
OVDK133827
Jan 7, 2019Acuity Surgical Devices, LLC
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link
Open, Classified
OVDK133827
Apr 9, 2018VGI Medical, LLC
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Terminated
OVDK151312
Dec 22, 2016Amendia, Inc
Optimus Fixed Awl
Terminated
OVDK132596
Feb 12, 2016Biomet Spine, LLC
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for s
Terminated
OVDK081501
Jan 15, 2015Biomet Spine, LLC
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into t
Terminated
OVDK123767
Jan 15, 2015Biomet Spine, LLC
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into
Terminated
OVDK123767
Jan 14, 2015Biomet Spine, LLC
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF
Terminated
OVDK123767
Nov 26, 2013Lanx, Inc.
LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consi
Terminated
OVDK123767
K131547

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