FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXETER MESH
K Number: K963940
·
Decision Feb 13, 1997
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
6
Applicant Total
36
Review Days
135
Basic Information
- Device Name
- EXETER MESH
- K Number
- K963940
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HOWMEDICA, INC.
- Date Received
- October 1, 1996
- Decision Date
- February 13, 1997
- Product Code
- JDJ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| 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 |
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