| Device Type ID | 4562 |
| Device Name | Prosthesis, Toe, Hemi-, Phalangeal |
| Regulation Description | Toe Joint Phalangeal (hemi-toe) Polymer Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3730 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KWD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4562 |
| Device | Prosthesis, Toe, Hemi-, Phalangeal |
| Product Code | KWD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Toe Joint Phalangeal (hemi-toe) Polymer Prosthesis. |
| CFR Regulation Number | 888.3730 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTHROCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHROSURFACE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFE SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Improper Or Incorrect Procedure Or Method | 2 |
Insufficient Information | 2 |
Device Expiration Issue | 1 |
Loose Or Intermittent Connection | 1 |
Dull, Blunt | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 12 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Integra LifeSciences Corp. | II | Dec-16-2014 |