ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
FDA 510(k) clearance K971036 · decided 1997-06-03
Clearance details
- K-number
- K971036
- Device name
- ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
- Applicant
- Interpore Intl.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-20
- Decision date
- 1997-06-03
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- GCY
- Device class
- 1
- Regulation number
- 878.4680
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM (K933319) | Birtcher Medical Systems, Inc. | 1993-10-27 |
| IMC 5.0MM IRRIGATION/ASPIRATION PROBE (K933305) | Inman Medical Corp. | 1993-10-05 |
| IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (K933306) | Inman Medical Corp. | 1993-10-05 |
| INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (K933170) | Inman Medical Corp. | 1993-09-16 |
| POOLE TIP SUCTION PROBE (K931950) | Mayaguez Medical Center | 1993-08-11 |
| 5.0 MM IRRIGATION/ASPIRATION PROBE (K931856) | Mayaguez Medical Center | 1993-08-10 |
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 |