FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCARF THREAD-HEAD (TM) HEAD SCREW
K Number: K971070
·
Decision Jul 9, 1997
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
15
Review Days
107
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Basic Information
- Device Name
- SCARF THREAD-HEAD (TM) HEAD SCREW
- K Number
- K971070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Landos, Inc.
- Date Received
- March 24, 1997
- Decision Date
- July 9, 1997
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Landos, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964226 | MEMORY STAPLE (20 SIZES AVAILABLE) | Aug 5, 1997 | Substantially Equivalent |
| K971069 | TWIST-OFF (TM) SCREW | Jul 9, 1997 | Substantially Equivalent |
| K971068 | 34MM SCARF THREAD-HEAD(TM) SCREW | Jul 9, 1997 | Substantially Equivalent |
| K961732 | KAR | Jul 8, 1997 | Substantially Equivalent |
| K970846 | 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD | Jun 5, 1997 | Substantially Equivalent for Some Indications |
| K953111 | CORAIL | Dec 27, 1996 | Substantially Equivalent |
| K962233 | TWIST-OFF SCREW | Oct 3, 1996 | Substantially Equivalent |
| K962236 | SCARF THREAD-HEAD SCREW | Sep 20, 1996 | Substantially Equivalent |
| K960642 | NANCY NAIL | May 17, 1996 | Substantially Equivalent |
| K943727 | BIOSTOP G BONE CEMENT RESTRICTOR | May 11, 1995 | Substantially Equivalent |