FDA.reportPublic FDA data

Bone matrix implant, synthetic

Definition
A 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.
GUDID devices
25
Last updated
2019-04-04 15:59:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
H9806150301S0CRANIOS ReinforcedSYNTHES (U.S.A.) LP615.03.01S2015-09-14
H9806150501S0CRANIOS ReinforcedSYNTHES (U.S.A.) LP615.05.01S2015-09-14
H9806151001S0CRANIOS ReinforcedSYNTHES (U.S.A.) LP615.10.01S2015-09-14
H9806160301S0CRANIOS ReinforcedSYNTHES (U.S.A.) LP616.03.01S2015-09-14
H9806160501S0CRANIOS ReinforcedSYNTHES (U.S.A.) LP616.05.01S2015-09-14
H9806161001S0CRANIOS ReinforcedSYNTHES (U.S.A.) LP616.10.01S2015-09-14
H98071000098S0ChronOSSYNTHES (U.S.A.) LP710.000.98S2015-09-14
H98071000198S0ChronOSSYNTHES (U.S.A.) LP710.001.98S2015-09-14
H98071000298S0ChronOSSYNTHES (U.S.A.) LP710.002.98S2015-09-14
H98071000398S0ChronOSSYNTHES (U.S.A.) LP710.003.98S2015-09-14
H98071001198S0ChronOSSYNTHES (U.S.A.) LP710.011.98S2015-09-14
H98071001498S0ChronOSSYNTHES (U.S.A.) LP710.014.98S2015-09-14
H98071004298S0ChronOSSYNTHES (U.S.A.) LP710.042.98S2015-09-14
H98071004798S0ChronOSSYNTHES (U.S.A.) LP710.047.98S2015-09-14
H98071005098S0ChronOSSYNTHES (U.S.A.) LP710.050.98S2015-09-14
H98071005798S0ChronOSSYNTHES (U.S.A.) LP710.057.98S2015-09-14
55060050780765Actifuse FlowApatech Ltd5060050780762018-10-10
55060050780772Actifuse FlowApatech Ltd5060050780772018-10-10
55060050780789Actifuse FlowApatech Ltd5060050780782018-10-10
00852371006002SignafuseBIOSTRUCTURES, LLCSGF-1502015-12-21
00852371006019SignafuseBIOSTRUCTURES, LLCSGF-0752015-12-21
00852371006026SignafuseBIOSTRUCTURES, LLCSGF-0372015-12-21
00852371006033OsteofuseBIOSTRUCTURES, LLCOF0012015-11-16
30808232000215NAStryker Corporation2102-01312015-09-24
00370050186091MBCPBIOMATLANTE0810B012015-11-10