The following data is part of a premarket notification filed by Medcad with the FDA for Medcad Accushape Titanium Patient-specific Cranial Implant.
| Device ID | K220357 |
| 510k Number | K220357 |
| Device Name: | MedCAD AccuShape Titanium Patient-Specific Cranial Implant |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | MedCAD 501 S 2nd Ave, Suite A-1000 Dallas, TX 75226 |
| Contact | Brian Buss |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810007631066 | K220357 | 000 |
| 00810007631059 | K220357 | 000 |
| 00810007631042 | K220357 | 000 |
| 00810007631035 | K220357 | 000 |
| 00810007631028 | K220357 | 000 |
| 00810007631011 | K220357 | 000 |
| 00810007631004 | K220357 | 000 |
| 00810007630991 | K220357 | 000 |