Device Type ID | 4604 |
Device Name | Accessories, Fixation, Spinal Intervertebral Body |
Regulation Description | Orthopedic Manual Surgical Instrument. |
Regulation Medical Specialty | Orthopedic |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 888.4540 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | LYQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 4604 |
Device | Accessories, Fixation, Spinal Intervertebral Body |
Product Code | LYQ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Orthopedic Manual Surgical Instrument. |
CFR Regulation Number | 888.4540 [🔎] |
Device Problems | |
---|---|
Packaging Problem | 1 |
Product Quality Problem | 1 |
Total Device Problems | 2 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Medtronic Sofamor Danek USA Inc | II | Feb-05-2015 |
2 | Zimmer Biomet Spine Inc. | II | May-15-2017 |