FDA.reportPublic FDA data

OsteoVation

Primary DI
00813845020092
Brand
OsteoVation
Company
SKELETAL KINETICS LLC
Model
390-2110
Catalog number
390-2110
Device description
OsteoVation Impact 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
OTC
false
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
00813845020092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813845020092008138450200928138450200920813845020092

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and 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. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
140071411
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
00813845021105CranioSculptC-C3CCC-C3CC2019-12-17
00813845021112CranioSculptC-C5CCC-C5CC2019-12-17
00813845021129CranioSculptC-C10CCC-C10CC2019-12-17
00842528100172OsteoMed390-6005390-60052016-10-13
00842528100189OsteoMed390-6010390-60102016-10-13
00842528104156OsteoMed390-6003390-60032017-04-20
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
00813845020054OsteoVation390-2005390-20052015-10-22
00813845020061OsteoVation390-2010390-20102015-10-22
00813845020078OsteoVation390-2103390-21032015-10-22
00813845020085OsteoVation390-2105390-21052015-10-22
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

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