FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAPERED COMPRESSION PIN
K Number: K051740
·
Decision Sep 6, 2005
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
16
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TAPERED COMPRESSION PIN
- K Number
- K051740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexa Orthopedics, Inc.
- Date Received
- June 28, 2005
- Decision Date
- September 6, 2005
- Product Code
- JDW
- 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 |
|---|---|---|---|
| JDW | Pin, Fixation, Threaded | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDW), ordered by most recent decision date.
XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
FDA 510(k)
FDA Class 2
·Orthopedic
Meduloc Intramedullary Fracture Fixation (IFF) System
FDA 510(k)
FDA Class 2
·Orthopedic
XT3 System
FDA 510(k)
FDA Class 2
·Orthopedic
MAVERICK Mini External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MAVERICK External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Steinmann Pins and Kirschner Wires
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Nexa Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072710 | NEXFIX COMPRESSION PIN | Nov 8, 2007 | Substantially Equivalent |
| K071147 | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM | Jul 20, 2007 | Substantially Equivalent |
| K070688 | NEXFIX COMPRESSION STAPLE | May 18, 2007 | Substantially Equivalent |
| K060386 | NEXA CARPO METACARPAL IMPLANT | May 10, 2006 | Substantially Equivalent |
| K060071 | NEXA COMPRESSION SCREW | Jan 26, 2006 | Substantially Equivalent |
| K053408 | NEXA BONE PLATE AND SCREW SYSTEM | Dec 22, 2005 | Substantially Equivalent |
| K053394 | NEXA BONE SCREW SYSTEM | Dec 14, 2005 | Substantially Equivalent |
| K051406 | OSTEOCURE RESORBABLE BEAD KIT | Aug 1, 2005 | Substantially Equivalent |
| K033046 | SUBTALAR PEG IMPLANT | Dec 23, 2003 | Substantially Equivalent |
| K032902 | SUBTALAR ARTHRORISIS IMPLANT | Dec 15, 2003 | Substantially Equivalent |