FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE
K Number: K091207
·
Decision Feb 15, 2011
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
10
Review Days
662
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Basic Information
- Device Name
- SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE
- K Number
- K091207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgicraft , Ltd.
- Date Received
- April 24, 2009
- Decision Date
- February 15, 2011
- Product Code
- HTN
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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Other Clearances by Surgicraft , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K072370 | SURGICRAFT SURGICAL MESH SYSTEM | Jul 24, 2008 | 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 |