The following data is part of a premarket notification filed by Vanduzen Dba Medcad with the FDA for Medcad Accushape (tm) Peek Patient Specific Cranial / Craniofacial Implant.
| Device ID | K110684 |
| 510k Number | K110684 |
| Device Name: | MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | VANDUZEN DBA MEDCAD 1201 RICHARDSON SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford VANDUZEN DBA MEDCAD 1201 RICHARDSON SUITE 280 Richardson, TX 75080 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-11 |
| Decision Date | 2011-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810007630137 | K110684 | 000 |
| 00810007630021 | K110684 | 000 |
| 00810007630014 | K110684 | 000 |
| 00810007630007 | K110684 | 000 |
| 00810007630175 | K110684 | 000 |
| 00810007630168 | K110684 | 000 |
| 00810007630632 | K110684 | 000 |
| 00810007630625 | K110684 | 000 |
| 00810007630618 | K110684 | 000 |
| 00810007630038 | K110684 | 000 |
| 00810007630045 | K110684 | 000 |
| 00810007630120 | K110684 | 000 |
| 00810007630113 | K110684 | 000 |
| 00810007630106 | K110684 | 000 |
| 00810007630090 | K110684 | 000 |
| 00810007630083 | K110684 | 000 |
| 00810007630076 | K110684 | 000 |
| 00810007630069 | K110684 | 000 |
| 00810007630052 | K110684 | 000 |
| 00810007630182 | K110684 | 000 |