FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAPP SPINAL BUTTON
K Number: K843368
·
Decision Sep 12, 1984
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
9
Review Days
15
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Basic Information
- Device Name
- KAPP SPINAL BUTTON
- K Number
- K843368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Kapp Surgical Instrument, Inc.
- Date Received
- August 28, 1984
- Decision Date
- September 12, 1984
- Product Code
- HTN
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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|---|---|---|---|
| K200289 | Michler-Kapp Cardiovascular Vent Catheter | Jan 28, 2021 | Substantially Equivalent |
| K072216 | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 | Nov 9, 2007 | Substantially Equivalent |
| K050384 | KAPP BARI-RING, MODEL KS-BR-2005 | Jan 13, 2006 | Substantially Equivalent |
| K050655 | MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 | Aug 8, 2005 | Substantially Equivalent |
| K050657 | MONDEAL CONTOUR HO SYSTEM | Aug 8, 2005 | Substantially Equivalent |
| K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | Jul 28, 2004 | Substantially Equivalent |
| K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | Aug 29, 2003 | Substantially Equivalent |
| K844177 | COSGROVE MITRAL VALVE RETRACTOR | Nov 8, 1984 | Substantially Equivalent |