FDA.reportPublic FDA data

OssGro

Primary DI
03700501810456
Brand
OssGro
Company
BIOMATLANTE
Model
LE1414C01
Catalog number
LE1414C01
Device description
Synthetic Resorbable Bone GraftWedge
Published
2017-09-22
Public version status
Update
Distribution status
Not 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
K051774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051774000MBCPBiomatlante2006-01-20MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700501810456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700501810456037005018104563700501810456

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
Device Size Text, specify0

Regulatory Flags#

DUNS number
493710719
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700501813402RESORBA Synthetic BoneSB0302G01SB0302G012024-05-17
03700501813426RESORBA Synthetic BoneSB0401GS01SB0401GS012024-05-17
03700501813440RESORBA Synthetic BoneSB0701M+G50SB0701M+G502024-05-17
03700501813457RESORBA Synthetic BoneSB0701M+G01SB0701M+G012024-05-17
03700501813488RESORBA Synthetic BoneSB0701M+GS50SB0701M+GS502024-05-17
03700501813495RESORBA Synthetic BoneSB0701M+GS01SB0701M+GS012024-05-17
03700501813549RESORBA Synthetic BoneSB0702M+G02SB0702M+G022024-05-17
03700501813501RESORBA Synthetic BoneSB1002PU50DESB1002PU50DE2024-05-16
03700501813518RESORBA Synthetic BoneSB1001PU01DESB1001PU01DE2024-05-16
03700501814133MBCP2301G032301G032024-04-02
03700501806961IN'OSS1101PU25DE1101PU25DE2016-05-11
03700501807760MBCP1301G5501301G5502016-05-11
03700501807777MBCP1301GS5501301GS5502016-05-11
03700501807784MBCP1301G5011301G5012016-05-11
03700501810296OssGroLE1102GS05LE1102GS052017-09-21
03700501810302OssgroLE1102GS10LE1102GS102018-06-20
03700501810319OssGroLE9902G10LE9902G102017-09-22
03700501810326OssGroLE0602G30LE0602G302017-09-22
03700501810333OssGroLE0503G05LE0503G052017-09-22
03700501810340OssGroLE9903G10LE9903G102017-09-22

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