FDA.reportPublic FDA data

WAVE D SPINAL SYSTEM

Primary DI
00643169245419
Brand
WAVE D SPINAL SYSTEM
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2670002
Device description
INSERTER 2670002 WAVE OUTER TUBE
Published
2015-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00643169245419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169245419006431692454196431692454190643169245419

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
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
04251631421351BEE PLIF CageNGMedical GmbHMAX2026-07-30