FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICRAFT SURGICAL MESH SYSTEM
K Number: K072370
·
Decision Jul 24, 2008
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
10
Review Days
336
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Basic Information
- Device Name
- SURGICRAFT SURGICAL MESH SYSTEM
- K Number
- K072370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgicraft , Ltd.
- Date Received
- August 23, 2007
- Decision Date
- July 24, 2008
- Product Code
- FTL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Surgicraft , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K091207 | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE | Feb 15, 2011 | Substantially Equivalent |
| K080447 | SURGICRAFT SCREW FIXATION SYSTEM | Jun 13, 2008 | Substantially Equivalent |
| K073109 | STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM | Jun 4, 2008 | Substantially Equivalent |
| K072415 | STALIF (TM) C | Jan 25, 2008 | Substantially Equivalent |
| K051027 | STALIF TT | Jun 29, 2005 | Substantially Equivalent |
| K041617 | STALIF TT | Sep 8, 2004 | Substantially Equivalent |
| K991662 | TITANIUM HARTSHILL SYSTEM | Nov 8, 1999 | Substantially Equivalent |
| K982719 | THE BONE TIE | Sep 25, 1998 | Substantially Equivalent |
| K965221 | RANSFORD CERVICAL FIXATION SYSTEM | Aug 7, 1997 | Substantially Equivalent |