FDA.reportPublic FDA data

Impulse AM Interbody Spacer System

Primary DI
00842048142041
Brand
Impulse AM Interbody Spacer System
Company
DEGEN MEDICAL, INC.
Model
0726-1622N
Catalog number
0726-1622N
Device description
16H X 22L X 12W Impulse AM Neutral Spacer
Published
2021-12-23
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
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
K210090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210090000Impulse AM Interbody Fusion SystemDegen Medical2021-08-30MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842048142041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842048142041008420481420418420481420410842048142041

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
Height16Millimeter
Length22Millimeter
Width12Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)240-7838customerservice@degenmedical.com

Regulatory Flags#

DUNS number
078812602
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842048154976Solar™ Interbody Fusion System12-28M12-28M2024-10-07
00842048182276DeGen Standard Instrumentation97-68M97-68M2025-03-10
00842048181910Solar™ Interbody Fusion System12-89M12-89M2024-06-10
00842048150343Solar™ Interbody Fusion System12-14M12-14M2023-07-15
00842048152996Latitude-C Cervical Interbody Spacer System03-03M03-03M2022-08-22
00842048137559Impulse Interbody Spacer System07-06M07-06M2021-12-22
00842048182726Latitude-C AM™ Cervical Interbody Fusion System0306-161405L040306-161405L042025-11-24
00842048182733Latitude-C AM™ Cervical Interbody Fusion System0306-161406L040306-161406L042025-11-24
00842048182740Latitude-C AM™ Cervical Interbody Fusion System0306-161407L040306-161407L042025-11-24
00842048182757Latitude-C AM™ Cervical Interbody Fusion System0306-161408L040306-161408L042025-11-24
00842048182764Latitude-C AM™ Cervical Interbody Fusion System0306-161409L040306-161409L042025-11-24
00842048182771Latitude-C AM™ Cervical Interbody Fusion System0306-161410L040306-161410L042025-11-24
00842048182788Latitude-C AM™ Cervical Interbody Fusion System0306-161411L040306-161411L042025-11-24
00842048182795Latitude-C AM™ Cervical Interbody Fusion System0306-161412L040306-161412L042025-11-24
00842048182801Latitude-C AM™ Cervical Interbody Fusion System0306-161413L040306-161413L042025-11-24
00842048182818Latitude-C AM™ Cervical Interbody Fusion System0306-161414L040306-161414L042025-11-24
00842048182979Latitude-C AM™ Cervical Interbody Fusion System0306-181410L040306-181410L042025-11-24
00842048182986Latitude-C AM™ Cervical Interbody Fusion System0306-181411L040306-181411L042025-11-24
00842048182993Latitude-C AM™ Cervical Interbody Fusion System0306-181412L040306-181412L042025-11-24
00842048183006Latitude-C AM™ Cervical Interbody Fusion System0306-181413L040306-181413L042025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14