FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LACTOSCREW SCREW ANCHOR
K Number: K033355
·
Decision Jun 30, 2004
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
34
Review Days
254
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Basic Information
- Device Name
- LACTOSCREW SCREW ANCHOR
- K Number
- K033355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Orthopedics, Inc.
- Date Received
- October 20, 2003
- Decision Date
- June 30, 2004
- 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 Biomet Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K070955 | ACID ETCHED LAG SCREWS | Oct 12, 2007 | Substantially Equivalent |
| K032286 | CALCIGEN PSI BONE GRAFT SUBSTITUTE | Nov 20, 2003 | Substantially Equivalent |
| K030048 | HA PMI FEMORAL HIP STEM | Feb 5, 2003 | Substantially Equivalent |
| K024086 | PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM | Jan 9, 2003 | Substantially Equivalent |
| K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM | Dec 13, 2002 | Substantially Equivalent |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | Dec 11, 2002 | Substantially Equivalent |
| K023357 | ARCPM 1050 RESIN-HIPS | Nov 6, 2002 | Substantially Equivalent |
| K021661 | RINGLOC CONSTRAINED LINERS | Oct 25, 2002 | Substantially Equivalent |