FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
K Number: K971036
·
Decision Jun 3, 1997
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
25
Review Days
75
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Basic Information
- Device Name
- ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
- K Number
- K971036
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Interpore Intl.
- Date Received
- March 20, 1997
- Decision Date
- June 3, 1997
- Product Code
- GCY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Interpore Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K981253 | ULTRACON ULTRAFILTRATOR | Dec 11, 1998 | Substantially Equivalent |
| K980817 | PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L | Sep 25, 1998 | Substantially Equivalent |
| K972842 | INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE | Oct 30, 1997 | Substantially Equivalent |
| K960945 | IMZ MEMBRANE TACK SYSTEM | May 24, 1996 | Substantially Equivalent |
| K960371 | INTERPORE THREADED IMPLANT | Mar 8, 1996 | Substantially Equivalent |
| K955492 | INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT | Jan 30, 1996 | Substantially Equivalent |
| K952167 | IMZ BONE TACK SYSTEM | Nov 21, 1995 | Substantially Equivalent |
| K950165 | INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS | Mar 28, 1995 | Substantially Equivalent |
| K922872 | INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. | Jul 25, 1994 | Substantially Equivalent |
| K922732 | INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER | Feb 10, 1994 | Substantially Equivalent |