FDA.reportPublic FDA data

OsseoSculpt Moldable ABG, 12cc

Primary DI
00812593021887
Brand
OsseoSculpt Moldable ABG, 12cc
Company
Biogennix, LLC
Model
SIN-8C-012-OSC
Device description
OsseoSculpt Moldable ABG, 12cc
Published
2025-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812593021887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812593021887008125930218878125930218870812593021887

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832270370
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812593023188osteoSPAN Granules120-10G2026-07-24
00812593023195SUMMIT Matrix Granules 10cc9241102026-07-24
00812593023201SUMMIT Matrix Granules 30cc9241302026-07-24
00812593023119NeoForm AWCNFAWC-0252026-04-27
00812593023126NeoForm AWCNFAWC-0502026-04-27
00812593023072NeoSurg Surgical CollagenNSC-3122026-04-22
00812593023089ossFX Surgical CollagenAXB-OSF-2502026-04-22
00812593023096ossFX Surgical CollagenAXB-OSF-5002026-04-22
00812593023102ColSyntekZS3001-52026-04-22
00812593023058Agilon Surgical Collagen +ASC-0152026-04-02
00812593023065Agilon Surgical Collagen +ASC-0302026-04-02
00812593023034CuraSurg Surgical CollagenCSC-0252026-04-01
00812593023041CuraSurg Surgical CollagenCSC-0502026-04-01
00812593023010Agilon Surgical Collagen+ASC-0252026-03-24
00812593023027Agilon Surgical Collagen+ASC-0502026-03-24
00812593021931Summit Moldable9242012025-02-21
00812593021948Summit Moldable9242022025-02-21
00812593021955Summit Moldable9242052025-02-21
00812593021962Summit Moldable9242102025-02-21
00812593021979Summit Strip9243052025-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889981189259Ballast™Seaspine Orthopedics CorporationMQV2023-08-29
10889981189266OsteoBallast™Seaspine Orthopedics CorporationMQV2023-08-29
10813954024551Opus StripCOLLAGEN MATRIX, INC.MQV2022-03-28
10889981283810TorrentSeaspine Orthopedics CorporationMQV2022-01-31
10889981283827TorrentSeaspine Orthopedics CorporationMQV2022-01-31
10889981283834TorrentSeaspine Orthopedics CorporationMQV2022-01-31
10889981283841TorrentSeaspine Orthopedics CorporationMQV2022-01-31
10889981283858Torrent CSeaspine Orthopedics CorporationMQV2022-01-31
10889981283865Torrent CSeaspine Orthopedics CorporationMQV2022-01-31
10889981283872Torrent CSeaspine Orthopedics CorporationMQV2022-01-31
10889981283889Torrent CSeaspine Orthopedics CorporationMQV2022-01-31
10889981283896Torrent CSeaspine Orthopedics CorporationMQV2022-01-31
10840642168709Tornado™Spine Wave, Inc.MQV2021-10-11
10889981123260IsoTis Mozaik™Seaspine Orthopedics CorporationMQV2020-10-19
10889981123277IsoTis Mozaik™Seaspine Orthopedics CorporationMQV2020-10-19
10889981123284IsoTis Mozaik™Seaspine Orthopedics CorporationMQV2020-10-19
10889981123291IsoTis Mozaik™Seaspine Orthopedics CorporationMQV2020-10-19
10889981123307IsoTis Mozaik™Seaspine Orthopedics CorporationMQV2020-10-19
10889981123314IsoTis Mozaik™Seaspine Orthopedics CorporationMQV2020-10-19
10889981123321OsteoStrux®Seaspine Orthopedics CorporationMQV2020-10-19
10889981123338OsteoStrux®Seaspine Orthopedics CorporationMQV2020-10-19
10889981123345OsteoStrux®Seaspine Orthopedics CorporationMQV2020-10-19
10889981123352OsteoStrux®Seaspine Orthopedics CorporationMQV2020-10-19
10889981123369OsteoStrux®Seaspine Orthopedics CorporationMQV2020-10-19
10889981123376OsteoStrux®Seaspine Orthopedics CorporationMQV2020-10-19
10840642159615Tornado™Spine Wave, Inc.MQV2020-04-15
10840642159622Tornado™Spine Wave, Inc.MQV2020-04-15
10840642159639Tornado™Spine Wave, Inc.MQV2020-04-15
10840642159646Tornado™Spine Wave, Inc.MQV2020-04-15
10840642159653Tornado™Spine Wave, Inc.MQV2020-04-15