FDA.reportPublic FDA data

Impulse Interbody Spacer System

Primary DI
00842048147374
Brand
Impulse Interbody Spacer System
Company
DEGEN MEDICAL, INC.
Model
07-36T1636N
Catalog number
07-36T1636N
Device description
16H x 36L x 12W Impulse Neutral Modular Trial
Published
2021-12-23
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
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
K201287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201287000Impulse Interbody Fusion SystemDegen Medical2020-12-22MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842048147374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842048147374008420481473748420481473740842048147374

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height16Millimeter
Length36Millimeter
Width12Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
078812602
Device count
1
Lot or batch
true
Sterilization required before use
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

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