FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MACROPORE FX, PS, NS, LP
K Number: K012413
·
Decision Sep 18, 2001
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
17
Review Days
50
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Basic Information
- Device Name
- MACROPORE FX, PS, NS, LP
- K Number
- K012413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Macropore Biosurgery, Inc.
- Date Received
- July 30, 2001
- Decision Date
- September 18, 2001
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Macropore Biosurgery, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042261 | MACROPORE PURICEL LIPOPLASTY SYSTEM | Sep 20, 2004 | Substantially Equivalent |
| K041105 | MACROPORE HYDROSORB SPINE SYSTEM | Jul 28, 2004 | Substantially Equivalent |
| K031955 | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET | Sep 22, 2003 | Substantially Equivalent |
| K031785 | MACROPORE CARDIO-WRAP (TS) | Sep 4, 2003 | Substantially Equivalent |
| K024169 | MACROPORE OS RECONSTRUCTION | Jul 1, 2003 | Substantially Equivalent |
| K023643 | MACROPORE SURGICAL BARRIER FILM | Feb 21, 2003 | Substantially Equivalent |
| K021164 | MACROPORE OS TRAUMA | Jul 1, 2002 | Substantially Equivalent |
| K012025 | MACROPORE SURGIWRAP (TS) | Dec 3, 2001 | Substantially Equivalent |
| K012769 | MACROPORE ENT RECONSTRUCTION FILM | Oct 25, 2001 | Substantially Equivalent |
| K011715 | MACROPORE IB RESORBABLE PLUG | Aug 27, 2001 | Unknown |