FDA.reportPublic FDA data

OsteoVation

Primary DI
00813845020054
Brand
OsteoVation
Company
SKELETAL KINETICS LLC
Model
390-2005
Catalog number
390-2005
Device description
OsteoVation Inject Bone Void Filler
Published
2015-10-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWPPROSTHESIS, CHIN, INTERNAL
GXPMETHYL METHACRYLATE FOR CRANIOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWPProsthesis, Chin, InternalGeneral, Plastic Surgery2
GXPMethyl Methacrylate For CranioplastyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813845020054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813845020054008138450200548138450200540813845020054

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile 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 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
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(972)677-4655cs@skeletalkinetics.com
+1(408)366-5014cs@skeletalkinetics.com

Regulatory Flags#

DUNS number
140071411
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813845021105CranioSculptC-C3CCC-C3CC2019-12-17
00813845021112CranioSculptC-C5CCC-C5CC2019-12-17
00813845021129CranioSculptC-C10CCC-C10CC2019-12-17
00842528104156OsteoMed390-6003390-60032017-04-20
00842528100172OsteoMed390-6005390-60052016-10-13
00842528100189OsteoMed390-6010390-60102016-10-13
00813845020009OsteoVation390-0002390-00022015-10-22
00813845020016OsteoVation390-0003390-00032015-10-22
00813845020023OsteoVation390-0005390-00052015-10-22
00813845020030OsteoVation390-0203390-02032015-10-22
00813845020047OsteoVation390-0205390-02052015-10-22
00813845020061OsteoVation390-2010390-20102015-10-22
00813845020078OsteoVation390-2103390-21032015-10-22
00813845020085OsteoVation390-2105390-21052015-10-22
00813845020092OsteoVation390-2110390-21102015-10-22
00813845020115OsteoVation390-4002390-40022015-10-22
00813845020122OsteoVation390-4003390-40032015-10-22
00813845020139OsteoVation390-4005390-40052015-10-22
00813845020146OsteoVation390-4010390-40102015-10-22
00813845020153OsteoVation390-4202390-42022015-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327300536MEDPORStryker Leibinger GmbH & Co. KGFWP2023-02-13
07613327300406MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300413MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300437MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300444MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300451MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300475MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300499MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300505MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300512MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300529MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300550MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300567MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
M724VMA11LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA11RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA13LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA13RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA7LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA7RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
08885013200393OsteomeshOSTEOPORE INTERNATIONAL PTE. LTD.GXP2018-07-19
08885013201192Osteoplug-COSTEOPORE INTERNATIONAL PTE. LTD.GXP2018-07-19
M724ACSIZNS1Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CEACSIZNS1Conform™ Extended AnatomicalIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CSCSIZNS1Curvilinear Silicone Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724EACSIZNS1Extended Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724FMGVSIZNS1Flowers Mandibular Glove® Sizers IMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724MPJSIZNS1Mandibular Pre Jowl® ImplantIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724TEACSIZNS1Terino Extended Anatomical™IMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724TMALSIZNS1Lateral Mandibular Angle™ SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724TSCIISIZNS1Terino Square Chin - Style II SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17