FDA.reportPublic FDA data

OsteoRepair-Inject

Primary DI
00850018568067
Brand
OsteoRepair-Inject
Company
DIMENSIONAL BIOCERAMICS LLC
Model
DB-O-I10CC
Catalog number
DB-O-I10CC
Device description
BONE VOID FILLER
Published
2021-07-05
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

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200752000DB-OrthopedicsDimensional Bioceramics, LLC2020-04-22MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018568067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018568067008500185680678500185680670850018568067

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080276169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018568197G21 Flex Beads, 5cc900217 5900217 52024-06-06
00850018568203G21 Flex Beads, 10cc900217 10900217 102024-06-06
00850018568210G21 Flex Beads, 20cc900217 20900217 202024-06-06
00850018568081Arthrex Calcium Sulfate BioBeads, 5 ccABS-3000-05ABS-3000-052023-09-05
00850018568098Arthrex Calcium Sulfate BioBeads, 10 ccABS-3000-10ABS-3000-102023-09-05
00850018568180Arthrex Calcium Sulfate BioBeads, 20 ccABS-3000-20ABS-3000-202023-09-05
00850018568005OsteoRepair-PasteDB-O-P3CCDB-O-P3CC2021-07-05
00850018568012OsteoRepair-PasteDB-O-P5CCDB-O-P5CC2021-07-05
00850018568029OsteoRepair-PasteDB-O-P10CCDB-O-P10CC2021-07-05
00850018568036OsteoRepair-PasteDB-O-P20CCDB-O-P20CC2021-07-05
00850018568043OsteoRepair-InjectDB-O-I3CCDB-O-I3CC2021-07-05
00850018568050OsteoRepair-InjectDB-O-I5CCDB-O-I5CC2021-07-05
00850018568074OsteoRepair-InjectDB-O-I20CCDB-O-I20CC2021-07-05
00850018568111CRANIOSCULPT-CDB-C-C5CCDB-C-C5CC2020-06-09
00850018568128CRANIOSCULPT-CDB-C-C10CCDB-C-C10CC2020-06-09
00850018568135CRANIOSCULPT-CDB-C-C20CCDB-C-C20CC2020-06-09
00850018568142CRANIOSCULPT-FLOWDB-C-FLOW3CCDB-C-FLOW3CC2020-06-09
00850018568159CRANIOSCULPT-FLOWDB-C-FLOW5CCDB-C-FLOW5CC2020-06-09
00850018568166CRANIOSCULPT-FLOWDB-C-FLOW10CCDB-C-FLOW10CC2020-06-09
00850018568173CRANIOSCULPT-FLOWDB-C-FLOW20CCDB-C-FLOW20CC2020-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
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