FDA.reportPublic FDA data

CRANIOS Reinforced

Primary DI
10887587058634
Brand
CRANIOS Reinforced
Company
Synthes GmbH
Model
615.03.01S
Catalog number
6150301S
Device description
CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXPMETHYL METHACRYLATE FOR CRANIOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102018000NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTYSynthes USA Products, LLC2010-09-23GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587058634PrimaryGS10
H9806150301S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705863410887587058634

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature043 Degrees Celsius
Special Storage Condition, Specify00.
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888118144430IPSKLS-Martin L.P.GXP2024-10-08
00888118144447IPSKLS-Martin L.P.GXP2024-10-08
00888118144454IPSKLS-Martin L.P.GXP2024-10-08
00888118144461IPSKLS-Martin L.P.GXP2024-10-08
00888118144478IPSKLS-Martin L.P.GXP2024-10-08
00888118144485IPSKLS-Martin L.P.GXP2024-10-08
00888118144492IPSKLS-Martin L.P.GXP2024-10-08
00888118144508IPSKLS-Martin L.P.GXP2024-10-08
00888118144515IPSKLS-Martin L.P.GXP2024-10-08
00888118144522IPSKLS-Martin L.P.GXP2024-10-08
00888118144539IPSKLS-Martin L.P.GXP2024-10-08
00888118144546IPSKLS-Martin L.P.GXP2024-10-08
00888118144553IPSKLS-Martin L.P.GXP2024-10-08
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
08885013201307OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
08885013201314OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
00888118140050IPSKLS-Martin L.P.GXP2023-03-22
00888118140067IPSKLS-Martin L.P.GXP2023-03-22
00888118140074IPSKLS-Martin L.P.GXP2023-03-22
00888118140081IPSKLS-Martin L.P.GXP2023-03-22
00888118140098IPSKLS-Martin L.P.GXP2023-03-22
00888118140104IPSKLS-Martin L.P.GXP2023-03-22
00888118140111IPSKLS-Martin L.P.GXP2023-03-22
00888118140128IPSKLS-Martin L.P.GXP2023-03-22
00888118140135IPSKLS-Martin L.P.GXP2023-03-22
00888118140142IPSKLS-Martin L.P.GXP2023-03-22