FDA.reportPublic FDA data

OsteoGen Plugs - Large, 10x20mm

Primary DI
00855286006075
Brand
OsteoGen Plugs - Large, 10x20mm
Company
Impladent, Ltd.
Model
OPL1020
Device description
OsteoGen Plugs. OsteoGen bone graft combined with a bovine achilles tendon carrier.
Published
2015-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090794000OSTEOTAPEImpladent , Ltd.2009-12-10NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855286006075PackageGS15In Commercial Distribution
00855286006402PackageGS110In Commercial Distribution
00855286006013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855286006075008552860060758552860060750855286006075
00855286006402008552860064028552860064020855286006402
00855286006013008552860060138552860060130855286006013

GMDN Terms#

Term, Definition table
TermDefinition
Composite bone graftAn implantable device that combines various bone substitute materials and/or bone growth factors to serve as a structural bone replacement typically when bone is lost due to trauma or osteoporosis. It is available in a variety of combinations such as collagen/ceramic, or polytetrafluoroethylene (PTFE) with carbon fibres.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
199838400
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
00855286006136TriStar Screws - 3mm (Pack of 5)TRI-032015-10-27
00855286006143TriStar Screws - 4mm (Pack of 5)TRI-042015-10-27
00855286006150TriStar Screws - 5mm (Pack of 5)TRI-052015-10-27
00855286006167TriStar Screws - 6mm (Pack of 5)TRI-062015-10-27
00855286006174TriStar Screws - 8mm (Pack of 5)TRI-082015-10-27
00855286006181TriStar Screws - 10mm (Pack of 5)TRI-102015-10-27
00855286006198TriStar Screws - 12mm (Pack of 5)TRI-122015-10-27
00855286006204TriStar Screws - 14mm (Pack of 5)TRI-142015-10-27
00855286006211TriStar Screws - 15mm (Pack of 5)TRI-152015-10-27
00855286006228TriStar Screws - 18mm (Pack of 5)TRI-182015-10-27
00855286006235TriStar Screws - 21mm (Pack of 5)TRI-212015-10-27
00855286006242TriStar Screws - 24mm (Pack of 5)TRI-242015-10-27
00855286006273OsteoGen Strip - SmallOSS122032023-08-22
00855286006358OsteoGen BlockOBB1015172023-08-22
00855286006426OsteoGen Plugs - Extra LargeOPXL15202023-08-22
00855286006112OsteoGen StripOSL204032023-08-22
00855286006129OsteoGen StripOSL204032023-08-22
00855286006266OsteoGen Strip - SmallOSS122032023-08-22
00855286006341OsteoGen BlockOBB1015172023-08-22
00855286006433OsteoGen Plugs - Extra LargeOPXL15202023-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800045217584Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217591Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217607Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217614Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217621Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217638Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217645Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08806387896760Renew-Cera, (BoneMedik-DM 0.3~0.5mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896777Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896784Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896791Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896807Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896814Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896821Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896838Renew-Cera, (BoneMedik-DM 0.5~1.0mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896845Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896852Renew-Cera, (BoneMedik-DM 0.3 ~ 0.5 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896869Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896876Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08800039000000THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
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