Definition: Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeo
| Device Type ID | 1616 |
| Device Name | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Regulation Description | Ear, Nose, And Throat Synthetic Polymer Material. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.3620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1616 |
| Device | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Product Code | NHB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ear, Nose, And Throat Synthetic Polymer Material. |
| CFR Regulation Number | 874.3620 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SPIROX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Fracture | 19 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Appropriate Term/Code Not Available | 7 |
Migration Or Expulsion Of Device | 5 |
Failure To Advance | 2 |
Packaging Problem | 2 |
Patient Device Interaction Problem | 1 |
Migration | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 49 |