FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
ANCHORMAN Tibial Ligament Fixation Device
K Number: K170388
·
Decision Jul 25, 2017
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
5
Review Days
167
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Basic Information
- Device Name
- ANCHORMAN Tibial Ligament Fixation Device
- K Number
- K170388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Summit Medical , Ltd.
- Date Received
- February 8, 2017
- Decision Date
- July 25, 2017
- 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 Summit Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K173110 | GRAFTSITE | May 18, 2018 | Substantially Equivalent |
| K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 | Feb 14, 2003 | Substantially Equivalent |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET | Oct 25, 2002 | Substantially Equivalent |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 | Oct 9, 2002 | Substantially Equivalent |