FDA.reportPublic FDA data

Maxxeus

Primary DI
00855318006271
Brand
Maxxeus
Company
FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
Model
XL020
Published
2018-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K151209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151209000InterOssSigmagraft, Inc.2015-11-06NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855318006271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855318006271008553180062718553180062710855318006271

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071276372
Device count
1
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
00855318006233MaxxeusXK0052018-07-30
00855318006240MaxxeusXK0102018-07-30
00855318006257MaxxeusXK0202018-07-30
00855318006264MaxxeusXK0402018-07-30
00855318006288MaxxeusXL0402018-07-30
00855318006295MaxxeusXL0802018-07-30
00855318006301MaxxeusOK0252018-07-30
00855318006318MaxxeusOK0052018-07-30
00855318006325MaxxeusOL0052018-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809186541299EquimatrixNibec Co., Ltd.NPM2026-10-06
08809186540926EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540933EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540940EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540957EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540964EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540971EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540988EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540995EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541305EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541312EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541329EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541336EquimatrixNibec Co., Ltd.NPM2026-09-29
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