FDA.reportPublic FDA data

DBM Putty 10.0cc Jar

Primary DI
00849777009331
Brand
DBM Putty 10.0cc Jar
Company
Xtant Medical Holdings, Inc.
Model
DU-10PJ
Device description
ONE (1) PACKAGE - CONTAINING 10.0cc
Published
2018-04-09
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

Product Codes#

Code, Name table
CodeName
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130498000OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.2013-05-31MBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849777009331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849777009331008497770093318497770093310849777009331

GMDN Terms#

Term, Definition table
TermDefinition
Human-derived demineralized bone matrix implantAn 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.

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemX064-02402026-10-14
M697X07300151Xpress Minimally Invasive Pedicle Screw SystemX073-00152026-10-14
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemX073-00252026-10-14
M697X07300261Xpress Minimally Invasive Pedicle Screw SystemX073-00262026-10-14
M697X07300271Xpress Minimally Invasive Pedicle Screw SystemX073-00272026-10-14
M697X07300291Xpress Minimally Invasive Pedicle Screw SystemX073-00292026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemX073-825100-DL2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82560-DL2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82565-DL2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82570-DL2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82575-DL2026-10-14
M697X07382580DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82580-DL2026-10-14
M697X07382585DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82585-DL2026-10-14
M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82590-DL2026-10-14
M697X07382595DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82595-DL2026-10-14
00849777014144Vesuvius Flowable DBM, 1cc4104-K5010DP2026-09-14
00849777014151Vesuvius Flowable DBM, 2.5cc4104-K5025DP2026-09-14
00849777014168Vesuvius Flowable DBM, 5cc4104-K5050DP2026-09-14
00849777014175Vesuvius Flowable DBM, 10cc4104-K5100DP2026-09-14
00849777014182Vesuvius Flowable DBM, 0.5cc4104-K5005DP2026-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
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.MBP2019-03-29
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2019-03-29
00613994512758MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
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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
00613994986467MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
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00613994986498MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
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00613994986511MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986528MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986535MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986542MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986559MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00643169103986MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00643169103993MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00643169104006MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01