FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDPOR FIXATION SYSTEM
K Number: K091807
·
Decision Jun 28, 2010
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
19
Review Days
375
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Basic Information
- Device Name
- MEDPOR FIXATION SYSTEM
- K Number
- K091807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Porex Surgical, Inc.
- Date Received
- June 18, 2009
- Decision Date
- June 28, 2010
- 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 Porex Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102184 | MEDPOR CONTAIN CAN IMPLANT | Jan 7, 2011 | Substantially Equivalent |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Dec 3, 2010 | Substantially Equivalent |
| K091120 | MEDPOR CONTAIN IMPLANT | Mar 19, 2010 | Substantially Equivalent |
| K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | Feb 3, 2009 | Substantially Equivalent |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Aug 8, 2007 | Substantially Equivalent |
| K052297 | POREX ELECTROSURGERY NEEDLE | Mar 28, 2006 | Substantially Equivalent |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Jul 16, 2004 | Substantially Equivalent |
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH | Jun 30, 2004 | Substantially Equivalent |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Aug 5, 2002 | Substantially Equivalent |
| K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | Mar 14, 2002 | Substantially Equivalent |