Atlas FDA

PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L

FDA 510(k) clearance K980817 · decided 1998-09-25

Clearance details

K-number
K980817
Device name
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
Applicant
Interpore Intl.
Decision
Substantially Equivalent
Date received
1998-03-03
Decision date
1998-09-25
Days to decision
206 days
Clearance type
Traditional
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
PRO OSTEON 500 BONE GRAFT SUBSTITUTE (P860005/S012)Interpore Intl.2002-05-31
PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES (P860005/S011)Interpore Intl.1999-05-25
PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES (P860005/S009)Interpore Intl.1998-04-28
PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE (P860005/S010)Interpore Intl.1998-01-08
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S008)Interpore Intl.1997-09-11
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S007)Interpore Intl.1997-05-30
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S005)Interpore Intl.1996-07-18
INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX (P860005/S004)Interpore Intl.1994-08-08