Staple Driver
A staple driver is a handheld orthopedic instrument used to insert bone staples into bone tissue for fracture fixation, epiphysiodesis, or soft tissue reattachment. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject to general controls. Product code HXJ falls under the Orthopedic medical specialty.
Research product code HXJ 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
- HXJ
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K964953 | IN-TAC BONE ANCHOR SYSTEM | Feb 13, 1997 | Substantially Equivalent | Influence, Inc. |
| K962372 | UROTAC BONE ANCHOR INSERTER | Aug 19, 1996 | Substantially Equivalent | Influence, Inc. |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | Aug 02, 1993 | Substantially Equivalent | Micro Surgical Instruments Corp. |
| K834515 | FIXATION STAPLE KIT - DLIDE HAMMER | Apr 23, 1984 | Substantially Equivalent | Stryker Corp. |
| K830456 | STAPLE INSERTER-EXTRACTOR FOR ARTHROS | Mar 09, 1983 | Substantially Equivalent | Instrument Makar, Inc. |
| K830255 | OSTEOTOMY BONE STAPLE | Mar 09, 1983 | Substantially Equivalent | Techmedica, Inc. |
FEI Numbers
This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.