FDA.reportPublic FDA data

OsteoRepair-Paste

Primary DI
00850018568005
Brand
OsteoRepair-Paste
Company
DIMENSIONAL BIOCERAMICS LLC
Model
DB-O-P3CC
Catalog number
DB-O-P3CC
Device description
BONE VOID FILLER
Published
2021-07-05
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
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
00850018568005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018568005008500185680058500185680050850018568005

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and 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. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
080276169
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
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
false
Sterilization required before use
false

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
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
00850018568067OsteoRepair-InjectDB-O-I10CCDB-O-I10CC2021-07-05
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
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00810131880736OsteoFlo Synthetic HydroPutty HFP - 1ccSurgentec, LLCMQV2025-06-10
00810131880743OsteoFlo Synthetic HydroPutty HFP - 3ccSurgentec, LLCMQV2025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccSurgentec, LLCMQV2025-06-10
00810131880767OsteoFlo Synthetic HydroPutty HFP - 12ccSurgentec, LLCMQV2025-06-10
00810131881139OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881153OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881160OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881177OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALSurgentec, LLCMQV2025-06-10
00810131881184OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALSurgentec, LLCMQV2025-06-10
00858406007648OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccSurgentec, LLCMQV2025-06-10
00858406007655OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccSurgentec, LLCMQV2025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccSurgentec, LLCMQV2025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccSurgentec, LLCMQV2025-06-10
00858406007686OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccSurgentec, LLCMQV2025-06-10
00858406007693OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccSurgentec, LLCMQV2025-06-10
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2024-12-05
00850391007245Montage Settable Bone PuttyABYRX, INC.MQV2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.MQV2023-11-16
00850391007306Montage Flowable Settable Bone PasteABYRX, INC.MQV2023-11-16
00850391007313Montage Flowable Settable Bone PasteABYRX, INC.MQV2023-11-16
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00813954023915OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2020-09-15
00085412654362ALTAPOREApatech LtdMQV2019-12-11