Pin, Fixation, Resorbable, Hard Tissue
The Pin, Fixation, Resorbable, Hard Tissue is an orthopedic implant intended for small bone fixation in fracture, osteotomy, and arthrodesis applications. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance before marketing. The product code is OVZ, with regulation number 888.3040 under the Orthopedic specialty. This device carries an implant flag, indicating it is surgically placed within the body.
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Basic Information
- Product Code
- OVZ
- Device Class
- FDA class 2
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140625 | ORTHOSORB LS | Apr 18, 2014 | Substantially Equivalent | Biomet, Inc. |
| K111077 | ORTHOSORB RESORBABLE PINS | Jul 12, 2011 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K901456 | ORTHOSORB(R) ABSORBABLE PIN | Aug 15, 1990 | Substantially Equivalent | Johnson & Johnson International |
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.