FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K Number: K993903
·
Decision Feb 14, 2000
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
- K Number
- K993903
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Whiteside Biomechanics, Inc.
- Date Received
- November 16, 1999
- Decision Date
- February 14, 2000
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Whiteside Biomechanics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033313 | QUATRO M FEMORAL COMPONENT | Jul 28, 2004 | Substantially Equivalent |
| K012800 | SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM | May 3, 2002 | Substantially Equivalent |
| K003618 | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 | May 23, 2001 | Substantially Equivalent |
| K991678 | WHITESIDE BIOMECHANICS SPINAL SYSTEM | Aug 12, 1999 | Substantially Equivalent |
| K981238 | BIPOLAR FEMORAL HEAD | Aug 21, 1998 | Substantially Equivalent |
| K973261 | WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD | Nov 24, 1997 | Substantially Equivalent |
| K964616 | QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT | Aug 7, 1997 | Substantially Equivalent |
| K971721 | WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD | Jul 30, 1997 | Substantially Equivalent |
| K971718 | MICRO-SEAL ACETABULAR SYSTEM | Jul 23, 1997 | Substantially Equivalent |
| K964150 | WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD | Dec 27, 1996 | Substantially Equivalent |