FDA.reportPublic FDA data

PIVOX™ Oblique Lateral Spinal System

Primary DI
00763000878276
Brand
PIVOX™ Oblique Lateral Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2171145
Device description
TRIAL 2171145 O25 IB 20MM 6 DEG 8X45
Published
2025-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00763000878276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000878276007630008782767630008782760763000878276

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
00199150081905Medtronic Reusable InstrumentsX04260022026-07-30
00199150083107Medtronic Reusable InstrumentsEX10040072026-07-30
00199150083879Medtronic Reusable InstrumentsX09074112026-07-30
00763000887216MSB CD HORIZON Spinal System65435352026-07-30
00721902975158GDLH® Posterior Spinal SystemX0196-1112015-08-05
00721902975189GDLH® Posterior Spinal SystemX0196-1222015-08-05
00721902975219GDLH® Posterior Spinal SystemX0196-1262015-08-05
00721902975226GDLH® Posterior Spinal SystemX0196-1282015-08-05
00721902975233GDLH® Posterior Spinal SystemX0196-1302015-08-05
00673978130316GDLH® Posterior Spinal SystemX0196-1042015-08-24
00673978130347GDLH® Posterior Spinal SystemX0196-1072015-08-24
00673978130361GDLH® Posterior Spinal SystemX0196-1092015-08-24
00673978130385GDLH® Posterior Spinal SystemX0196-1122015-08-23
00673978130392GDLH® Posterior Spinal SystemX0196-1142015-08-24
00673978130408GDLH® Posterior Spinal SystemX0196-1162015-08-24
00673978130415GDLH® Posterior Spinal SystemX0196-1182015-08-24
00673978130422GDLH® Posterior Spinal SystemX0196-1202015-08-24
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35262026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35282026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-30
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166523028X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
04251631420095NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420101NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420118NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420125NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420132NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420149NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420156NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420163NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420170NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420187NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420194NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421153BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421177BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421184BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421207BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421214BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421221BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421252BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421269BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421276BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421283BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421306BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421313BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421320BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421337BEE PLIF CageNGMedical GmbHMAX2026-07-30