FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUGEN FX SCREW
K Number: K023022
·
Decision Oct 4, 2002
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
18
Review Days
23
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Basic Information
- Device Name
- NUGEN FX SCREW
- K Number
- K023022
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionx Implants, Inc.
- Date Received
- September 11, 2002
- Decision Date
- October 4, 2002
- Product Code
- HWC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Bionx Implants, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011569 | BIOSORBFX O/M 2.0/2/4 SYSTEM | Feb 22, 2002 | Substantially Equivalent |
| K013546 | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 | Nov 21, 2001 | Substantially Equivalent |
| K013057 | BIOCUFF,C, MODELS 236018, 236028, 236036 | Oct 12, 2001 | Substantially Equivalent |
| K012334 | CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 | Sep 19, 2001 | Substantially Equivalent |
| K010983 | PLLA PIN | Jun 13, 2001 | Substantially Equivalent |
| K010554 | MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A | May 25, 2001 | Substantially Equivalent |
| K010687 | BIOSORBFX AND BIOSORBPDX MESH | Mar 14, 2001 | Substantially Equivalent |
| K003659 | PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 | Feb 20, 2001 | Substantially Equivalent |
| K003970 | CONTOUR LABRAL NAIL, MODEL 533520A | Jan 12, 2001 | Substantially Equivalent |
| K003756 | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES | Jan 3, 2001 | Substantially Equivalent |