FDA.reportPublic FDA data

N/A

Primary DI
04250328205533
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
WD-13.24.0
Device description
WAVE PLIF CAGE DISTR. 13X24MM0 DEG
Published
2015-09-29
Public version status
Update
Distribution status
Not 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
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121333000WAVE D CAGEAdvanced Medical Technologies AG2012-06-29MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250328205533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250328205533042503282055334250328205533

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169964938GRAFTON™ DBMT42275INT2024-12-05
00643169965102GRAFTON PLUS™ DBMT45005INT2024-11-15
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUS0005052021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUS0050012021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUS0050052021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUS0051102021-03-12
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUS0060012021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUS0060022021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUS0060052021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUS0060102021-03-12
00643169965089GRAFTON® DBMT44150INT2019-02-07
00613994247612PROGENIX® PUTTY and PROGENIX® PLUS0051102019-03-29
00885074012292MASTERGRAFT® MATRIX76003102015-07-20
00885074012308MASTERGRAFT® MATRIX76003202015-07-20
00885074327266MASTERGRAFT® MATRIX76003052015-07-20
00885074478715MASTERGRAFT®Putty76007012015-07-20
00885074478753MASTERGRAFT®Putty76007022015-07-20
00885074478760MASTERGRAFT®Putty76007032015-07-20
00885074478784MASTERGRAFT®Putty76007062015-07-20
00885074478791MASTERGRAFT®Putty76007092015-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916245SABER-XA, Expandable Spacer, 40x30mm, 11mm, (6°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916252SABER-XA, Expandable Spacer, 40x30mm, 13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916269SABER-XA, Expandable Spacer, 40x30mm, 16mm, (18°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
07640139342287Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19