Fastener, Fixation, Biodegradable, Hard Tissue
The biodegradable hard tissue fixation fastener is an orthopedic implant used to fix or stabilize bony fragments or structures, designed to degrade and be resorbed by the body over time, eliminating the need for hardware removal surgery. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MBJ and it carries an implant flag; no regulation number or formal medical specialty has been assigned. It does not sustain life.
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Basic Information
- Product Code
- MBJ
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 3
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920188 | THREADED PINS | May 12, 1993 | Substantially Equivalent | Kirschner Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.