Staple, Absorbable
The Absorbable Staple is an orthopedic implant used for fixation of bone or soft tissue that is designed to be absorbed by the body over time, eliminating the need for removal surgery. Classified as FDA Class 2 under 21 CFR 888.3030 in the Orthopedic specialty, it requires 510(k) premarket notification. The product code is MNU, and it carries an implant flag.
Research product code MNU in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MNU
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241932 | OSSIOfiber® Compression Staple | Aug 28, 2024 | Substantially Equivalent | OSSIO , Ltd. |
| K233302 | OSSIOfiber® Compression Staple | Nov 16, 2023 | Substantially Equivalent | OSSIO , Ltd. |
| K212594 | OSSIOfiber® Staple | Jan 21, 2022 | Substantially Equivalent | OSSIO , Ltd. |
| K011172 | ARTHREX BIO-TRANSFIX | Jun 19, 2001 | Substantially Equivalent | Arthrex, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.