FDA.reportPublic FDA data

Trel X-Press 300

Primary DI
M386XPRES3251
Brand
Trel X-Press 300
Company
Integra Lifesciences Corporation
Model
XPRES325
Catalog number
XPRES325
Device description
Trel-XPress 300, 2.5cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Published
2015-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBPFiller, bone void, osteoinduction (w/o human growth factor)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061880000ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV2007-08-15MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780112563PrimaryGS10
M386XPRES3251SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011256310381780112563

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, human-derivedAn sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvnj@integralife.com
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780112075Integra OS™IOS10125IOS101252015-09-23
10381780112082Integra OS™IOS10155IOS101552015-09-23
10381780112426Trel-XC PasteTXCPA01TXCPA012015-09-22
10381780112433Trel-XC PasteTXCPA03TXCPA032015-09-22
10381780112440Trel-XC PasteTXCPA08TXCPA082015-09-22
10381780112457Trel-XC PuttyTXCPY05TXCPY052015-09-22
10381780112464Trel-XC PuttyTXCPY10TXCPY102015-09-22
10381780112471Trel-X PuttyTXP05TXP052015-09-22
10381780112488Trel-X PuttyTXP10TXP102015-09-22
10381780112495Trel-X GelTXG01TXG012015-09-22
10381780112501Trel-X GelTXG05TXG052015-09-22
10381780112518Trel X-Press 100XPRES110XPRES1102015-09-22
10381780112525Trel X-Press 100XPRES105XPRES1052015-09-22
10381780112532Trel X-Press 100XPRES125XPRES1252015-09-22
10381780112556Trel X-Press 300XPRES305XPRES3052015-09-25
10381780112563Trel X-Press 300XPRES325XPRES3252015-09-25
10381780112570Trel XPress 300CXPres3c10XPres3c102015-09-25
10381780114338Collage Osteoconductive Scaffold - Putty7100057100052015-09-22
10381780114345Collage Osteoconductive Scaffold - Putty7100107100102015-09-22
10381780114352Collage Osteoconductive Scaffold - Putty7100157100152015-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2024-12-05
00643169965102GRAFTON PLUS™ DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2024-11-15
00810076560007BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560380BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560649BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560656BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560663BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560670BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560687BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560694BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2019-03-29
00643169965089GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2019-02-07
00643169965096GRAFTON PLUS® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2018-04-05
00643169965065GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2018-01-26
00849777004695ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004701ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004718ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004725ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004732ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004749ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004824DBM Putty 2.5cc in a SyringeXtant Medical Holdings, Inc.MBP2016-10-18
00849777004831DBM Putty 5.0cc in a SyringeXtant Medical Holdings, Inc.MBP2016-10-18
00849777005630DBM Putty 10.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005647DBM Putty 1.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005654DBM Putty 2.5cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005661DBM Putty 5.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18