FDA.reportPublic FDA data

Amplify

Primary DI
00850009685254
Brand
Amplify
Company
Ventris Medical
Model
AMP-150
Device description
Surface Activated Bone Putty, Amplify, Large
Published
2024-07-26
Public version status
New
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
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009685254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009685254008500096852548500096852540850009685254

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight15Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-706-5551info@ventrismedical.com

Regulatory Flags#

DUNS number
081127567
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850009685346Backpack AFBAF-0012026-01-02
00850009685353Backpack AFBAF-0022026-01-02
00850009685117contour BA STRIPCBA-1600CBA-16002023-09-21
00850009685124contour BA STRIPCBA-800CBA-8002023-09-21
00850009685131contour BA STRIPCBA-400CBA-4002023-09-21
00850009685261contour BA STRIPCBA-1000CBA-10002023-09-21
00850009685278contour BA PUCKCBA-500CBA-5002023-09-21
00850009685285contour BA PUCKCBA-200CBA-2002023-09-21
00850009685384AmplifyAMP-0182025-07-29
00850009685292Connext Surgical Matrix CNX-015CNX-0152024-04-22
00850009685308Connext Surgical Matrix CNX-030CNX-0302024-04-22
00850009685315Connext Surgical Matrix CNX-045CNX-0452024-04-22
00850009685322Connext Surgical Matrix CNX-015CNX-0152024-04-24
00850009685339Connext Surgical Matrix CNX-030CNX-0302024-04-24
00850009685230AmplifyAMP-0372024-07-26
00850009685247AmplifyAMP-0752024-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2024-12-05
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00085412654362ALTAPOREApatech LtdMQV2019-12-11
00085412654379ALTAPOREApatech LtdMQV2019-12-11
00085412654386ALTAPOREApatech LtdMQV2019-12-11
00085412654393ALTAPOREApatech LtdMQV2019-12-11
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2019-03-29
00643169965089GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2019-02-07
00613994512758MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512765MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512772MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512789MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512796MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512802MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512819MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512826MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00643169965065GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2018-01-26
00643169141858MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2017-07-23
00643169719361MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169719378MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169719385MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169218093PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02
00643169218116PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02
00643169218130PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02