Product Code: OXJ FDA class 2 21 CFR 878.3300

Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

General, Plastic Surgery

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.

510(k)s
2
FEI Numbers
20
Registration Numbers
20
Unique Applicants
2
Years Active
3

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

For reinforcement of soft tissue where weakness exists in abdominal wall defects.

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K161939 Avance Abdominal Dressing Kit
K130852 AVANCE® FOAM ABDOMINAL DRESSING KIT

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.