FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXETER INTRAMEDULLARY BONE PLUG
K Number: K980843
·
Decision Jun 2, 1998
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
560
Applicant Total
36
Review Days
90
Basic Information
- Device Name
- EXETER INTRAMEDULLARY BONE PLUG
- K Number
- K980843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HOWMEDICA, INC.
- Date Received
- March 4, 1998
- Decision Date
- June 2, 1998
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
| K984251 | XIA SPINE SYSTEM | Feb 24, 1999 | Substantially Equivalent |
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| K983885 | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES | Jan 29, 1999 | Substantially Equivalent |
| K983358 | G/K SFN AND STN LOCKING NAILS | Nov 18, 1998 | Substantially Equivalent |
| K982463 | EXTRACRANIAL RADIOTHERAPY SYSTEM | Sep 30, 1998 | Substantially Equivalent |
| K982248 | HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A | Aug 31, 1998 | Substantially Equivalent |
| K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS | Jun 26, 1998 | Substantially Equivalent |
| K981283 | ROGACHEFSKY DISTAL RADIUS PLATES | Jun 10, 1998 | Substantially Equivalent |
| K980239 | PARTNERSHIP CALCAR FEMORAL COMPONENTS | Apr 16, 1998 | Substantially Equivalent |