FDA.reportPublic FDA data

TriPore

Primary DI
05051775000332
Brand
TriPore
Company
ORTHOGEM LTD
Model
1105-0515
Device description
TriPore HA in bottle blister, 0.25-0.5mm granules, 1.5cc
Published
2015-09-24
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
K070132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070132000TRIPORE, MODELS HA, BP90, BP15Orthogem Limited2007-07-13MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051775000332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051775000332050517750003325051775000332

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
220574912
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051775000271TriPore 1102-1408A2015-09-24
05051775000288TriPore1102-1412A2015-09-24
05051775000318TriPore1105-05052015-09-24
05051775000325TriPore1105-05102015-09-24
05051775000349TriPore1105-08052015-09-24
05051775000356TriPore1105-08102015-09-24
05051775000363TriPore1105-08152015-09-24
05051775000370TriPore1105-08202015-09-24
05051775000387TriPore1105-12102015-09-24
05051775000394TriPore1105-12152015-09-24
05051775000400TriPore1105-12202015-09-24
05051775000417PURblueP1104-08022015-09-24
05051775000424PURblueP1104-08052015-09-24
05051775000431PURblueP1104-12022015-09-24
05051775000448PURblueP1104-12052015-09-24
05051775000455PURblueP1103-12102015-09-24
05051775000462PURblueP1103-12152015-09-24
05051775000479PURblueP1104-24052015-09-24
05051775000486PURblueP1103-24102015-09-24
05051775000493PURblueP1103-24152015-09-24

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Primary DI, Brand, Company table
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