Panels › General, Plastic Surgery › Product code KKY · Class 2
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation 878.3500
0510(k)s in 12 months (25 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in KKY
| Company | 510(k)s | Recalls |
|---|---|---|
| Ceremed , Inc. | 4 | 0 |
| Stryker Craniomaxillofacial Division | 0 | 4 |
| Matrix Surgical Holdings, LLC | 0 | 3 |
| Oxford Performance Materials | 2 | 0 |
| Associated Hospital Services, Inc. | 1 | 0 |
| Biomet, Inc. | 1 | 0 |
| Biomet Microfixation, LLC | 0 | 1 |
| Biomet Ussc Orthopedics | 1 | 0 |
| Hohenstein Enterprises, Inc. | 1 | 0 |
| Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2019 | Matrix Surgical Holdings, LLC OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial r Terminated |
KKY | K123908 |
| Jan 30, 2019 | Matrix Surgical Holdings, LLC OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial r Terminated |
KKY | K123908 |
| Feb 28, 2017 | Matrix Surgical Holdings, LLC OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right Terminated |
KKY | K123908 K133046 |
| Jun 13, 2016 | Biomet Microfixation, LLC Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made.
HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/d Terminated |
KKY | K924935 |
| Feb 12, 2014 | Stryker Howmedica Osteonics Corp. Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2)
5444-01-102 Host Bone; Howmedica Osteonics Corp.
325 Corporate Drive, Mahwah, NJ 07430 USA.
Designed individually for each Terminated |
KKY | K103010 |
| Dec 18, 2008 | Stryker Craniomaxillofacial Division Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104.
Custom cranial implant designed individually for each patient to cor Terminated |
KKY | K043250 |
| Dec 18, 2008 | Stryker Craniomaxillofacial Division Stryker Custom Cranial Implant Kit, large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00103.
Custom cranial implant designed individually for each patient to correct t Terminated |
KKY | K043250 |
| Dec 18, 2008 | Stryker Craniomaxillofacial Division Stryker Custom Cranial Implant Kit, medium. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00102.
Custom cranial implant designed individually for each patient to correct Terminated |
KKY | K043250 |
| Dec 18, 2008 | Stryker Craniomaxillofacial Division Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00101.
Custom cranial implant designed individually for each patient to correct t Terminated |
KKY | K043250 |
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