FDA.reportPublic FDA data

ProSpace™ DBM Moldable Putty (Jar)

Primary DI
00849777004732
Brand
ProSpace™ DBM Moldable Putty (Jar)
Company
Xtant Medical Holdings, Inc.
Model
ME915
Device description
5.0cc
Published
2016-10-18
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

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
00849777004732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849777004732008497770047328497770047320849777004732

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081224143
Device count
1
HCT/P
true
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311224425Cortera Spinal Fixation System150211-553002026-05-18
00840311224432Cortera Spinal Fixation System150211-554002026-05-18
00840311224449Cortera Spinal Fixation System150211-555002026-05-18
00840311224456Cortera Spinal Fixation System150211-556002026-05-18
00840311224463Cortera Spinal Fixation System150211-603002026-05-18
00840311224470Cortera Spinal Fixation System150211-604002026-05-18
00840311224487Cortera Spinal Fixation System150211-605002026-05-18
00840311224494Cortera Spinal Fixation System150211-606002026-05-18
00840311227181Cortera Spinal Fixation System150220-553002026-05-18
00840311227198Cortera Spinal Fixation System150220-554002026-05-18
00840311227204Cortera Spinal Fixation System150220-555002026-05-18
00840311227211Cortera Spinal Fixation System150220-556002026-05-18
00840311227228Cortera Spinal Fixation System150220-603002026-05-18
00840311227235Cortera Spinal Fixation System150220-604002026-05-18
00840311227242Cortera Spinal Fixation System150220-605002026-05-18
00840311227259Cortera Spinal Fixation System150220-606002026-05-18
00840311212767Fortilink-C IBF System65-C-1012-10-6L65-C-1012-10-6L2026-04-30
00840311212774Fortilink-C IBF System65-C-1012-11-6L65-C-1012-11-6L2026-04-30
00840311212798Fortilink-C IBF System65-C-1012-6-6L65-C-1012-6-6L2026-04-30
00840311212804Fortilink-C IBF System65-C-1012-7-6L65-C-1012-7-6L2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27
03760191134935MectaBlast GranulesNORAKERMQV2026-05-27
03760191134942MectaBlast GranulesNORAKERMQV2026-05-27
08719699710122MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710276MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710283MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710290MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710306MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710313MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710320MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710337MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710344MagnetOsKuros Biosciences B.V.MQV2018-01-08