SU-POR SURGICAL IMPLANT
FDA 510(k) clearance K140437 · decided 2014-06-13
Clearance details
- K-number
- K140437
- Device name
- SU-POR SURGICAL IMPLANT
- Applicant
- Poriferous, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-02-21
- Decision date
- 2014-06-13
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- KKY
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Newnan, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Longeviti PorousFit implant (K211514) | Longeviti Neuro Solutions, LLC | 2021-07-15 |
| OsteoFab Patient Specific Facial Device (K161052) | Oxford Performance Materials, Inc. | 2016-07-20 |
| Biopor, AOC Porous Polyethylene, Cerepor (K160988) | Ceremed , Inc. | 2016-07-14 |
| BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (K141880) | Ceremed , Inc. | 2015-04-16 |
| OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (K133809) | Oxford Performance Materials | 2014-07-28 |
| OMNIPORE CUSTOMIZED SURGICAL IMPLANTS (K133046) | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2014-05-14 |
| OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES (K123908) | Matrix Surgical USA | 2013-07-31 |
| SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS (K111323) | Synthes, Inc. | 2011-11-16 |
| STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K103010) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010-10-26 |
| AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT (K080507) | Ceremed , Inc. | 2008-04-21 |
| BONALIVE GRANULES AND BONALIVE PLATES (K071937) | Vivoxid , Ltd. | 2007-10-19 |
| STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K043250) | Stryker Leibinger | 2005-04-15 |
Recalls involving this device
No recalls on record reference this clearance.