FDA.reportPublic FDA data

PIVOX™ Oblique Lateral Spinal System

Primary DI
00643169606159
Brand
PIVOX™ Oblique Lateral Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2133455
Device description
SPACER 2133455 OLIF25 27MM 18 DEG 14X55
Published
2016-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152277000PIVOX(tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015-11-13MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169606159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169606159006431696061596431696061590643169606159

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle18degree
Height14Millimeter
Length55Millimeter
Width27Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00721902298431TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0182015-08-18
00721902298448TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0202015-08-18
00721902298455TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0222015-08-18
00721902298462TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0242015-08-19
00721902298479TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0262015-08-18
00763000704483MSB CAPSTONE CONTROL™ Spinal System40016272026-07-20
00763000879556MSB Reusable Instruments5210-10222026-07-20
00763000992439MSB INFINITY OCT SystemG365PT40262026-07-20
00763000992446MSB INFINITY OCT SystemG365PT40282026-07-20
00763000993092MSB INFINITY OCT SystemG36555352026-07-20
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-07-23
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22