INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
FDA 510(k) clearance K972842 · decided 1997-10-30
Clearance details
- K-number
- K972842
- Device name
- INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
- Applicant
- Interpore Intl.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-01
- Decision date
- 1997-10-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LYC
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- 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
| Record | Firm | Date |
|---|---|---|
| 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 |