FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
K Number: K982390
·
Decision Sep 14, 1998
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
302
Review Days
67
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
- CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
- K Number
- K982390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wrightmedicaltechnologyinc
- Date Received
- July 9, 1998
- Decision Date
- September 14, 1998
- Product Code
- KTW
- 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 |
|---|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTW), ordered by most recent decision date.
PK High Tibial Osteotomy Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
AOS Anterolateral Proximal Humeral Plate
FDA 510(k)
FDA Class 2
·Orthopedic
Phantom Small Bone Intramedullary Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
AOS Anterolateral Proximal Humeral Plate
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
FDA 510(k)
FDA Class 2
·Orthopedic
AOS PROXIMAL HUMERAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Wrightmedicaltechnologyinc
| K Number | Device Name | ||
|---|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment System | Jan 27, 2023 | Substantially Equivalent |
| K213342 | PRO-DENSE LoVisc Bone Graft Substitute | Jan 5, 2022 | Substantially Equivalent |
| K212996 | Sterile PHALINX Hammertoe System | Nov 16, 2021 | Substantially Equivalent |
| K202815 | PROPHECY Preoperative Navigation Alignment System | Mar 10, 2021 | Substantially Equivalent |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | Jan 8, 2021 | Substantially Equivalent |
| K200507 | PRO-DENSE LoVisc Bone Graft Substitute | Oct 21, 2020 | Substantially Equivalent |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System | Jun 8, 2020 | Substantially Equivalent |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Aug 22, 2019 | Substantially Equivalent |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) System | Aug 13, 2019 | Substantially Equivalent |
| K183620 | PROSTEP TBC Implant System | Jun 6, 2019 | Substantially Equivalent |