Definition: A Pedicle Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Pedicle Screws That Are Used To Anchor Pedicle Screw Spinal Systems Onto The Posterior Elements Of The Spine. The Device Uti
| Device Type ID | 4691 |
| Device Name | Pedicle Screw Placement Guide |
| Physical State | A Pedicle Screw Placement Guide, Made Of Polymeric Or Metallic Material, Which Contains A Patient-matched Surface That Is Congruent To The Mating Surface Of The Posterior Elements Of The Spine. |
| Technical Method | The Device Consists Of A Both A Software And Hardware Component. The Software Component Generates A Pre-operative Plan Based On Medical Imaging Data. The Hardware Component Consists Of A Patient-matched Guide That Is Positioned Onto The Posterior Ele |
| Target Area | Spine |
| Regulation Description | Thoracolumbosacral Pedicle Screw System. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4691 |
| Device | Pedicle Screw Placement Guide |
| Product Code | PQC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thoracolumbosacral Pedicle Screw System. |
| CFR Regulation Number | 888.3070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDACTA INTERNATIONAL SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |