Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
The Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects is a non-absorbable surgical mesh implant used for reinforcement of soft tissue where weakness exists in abdominal wall defects. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OXJ, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.
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Basic Information
- Product Code
- OXJ
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For reinforcement of soft tissue where weakness exists in abdominal wall defects.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.