K190044 is an FDA 510(k) clearance for the VSP Orthopedics System. This device is classified as a Orthopaedic Surgical Planning And Instrument Guides (Class II - Special Controls, product code PBF).
Submitted by 3D Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on August 21, 2019, 224 days after receiving the submission on January 9, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures..
| 510(k) Number | K190044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2019 |
| Decision Date | August 21, 2019 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PBF - Orthopaedic Surgical Planning And Instrument Guides |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures. |