FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TI - SCREW ANCHOR SP
K Number: K042460
·
Decision Oct 29, 2004
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
17
Review Days
49
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Basic Information
- Device Name
- TI - SCREW ANCHOR SP
- K Number
- K042460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrotek, Inc.
- Date Received
- September 10, 2004
- Decision Date
- October 29, 2004
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Arthrotek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061776 | ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE | Sep 25, 2006 | Substantially Equivalent |
| K061801 | 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS | Aug 7, 2006 | Substantially Equivalent |
| K061657 | HITCH LACTOSORB SUTURE ANCHOR | Jul 25, 2006 | Substantially Equivalent |
| K061389 | ALLTHREAD LACTOSORB SUTURE ANCHOR | Jul 19, 2006 | Substantially Equivalent |
| K060693 | MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR | Jun 6, 2006 | Substantially Equivalent |
| K053461 | EZLOC FEMORAL FIXATION DEVICE | Feb 3, 2006 | Substantially Equivalent |
| K051069 | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER | Jun 29, 2005 | Substantially Equivalent |
| K041274 | RESORBABLE INTERFERENCE SCREW | Jul 28, 2004 | Substantially Equivalent |
| K041261 | FEMORAL HOOK | Jun 7, 2004 | Substantially Equivalent |
| K040604 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | Jun 4, 2004 | Substantially Equivalent |