FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
THERMOFX MESH
K Number: K003757
·
Decision Feb 7, 2001
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
12
Review Days
63
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Basic Information
- Device Name
- THERMOFX MESH
- K Number
- K003757
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionx Implants, Ltd.
- Date Received
- December 6, 2000
- Decision Date
- February 7, 2001
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Bionx Implants, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K030388 | IMPACT SUTURE ANCHOR. MODEL 433510 | Apr 24, 2003 | Substantially Equivalent |
| K020056 | DUET SUTURE ANCHOR | Jun 26, 2002 | Substantially Equivalent |
| K012001 | SMARTSCREW | Jul 18, 2001 | Substantially Equivalent |
| K012000 | 1.5MM BONE FIXATION KIT | Jul 18, 2001 | Substantially Equivalent |
| K003077 | SMARTSCREW MODEL 222006...227510 | Apr 26, 2001 | Substantially Equivalent |
| K000616 | SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 | Mar 23, 2000 | Substantially Equivalent |
| K993074 | SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 | Dec 10, 1999 | Substantially Equivalent |
| K993073 | SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 | Dec 6, 1999 | Substantially Equivalent |
| K993453 | MENISCUS ARROW, MODELS 531110, 531113, 531116 | Nov 9, 1999 | Substantially Equivalent |
| K992947 | CANNULATED SMARTSCREW MODELS 224540C, 224570C | Sep 21, 1999 | Substantially Equivalent |