FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
K Number: K083469
·
Decision Feb 13, 2009
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
- K Number
- K083469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Metasurg
- Date Received
- November 24, 2008
- Decision Date
- February 13, 2009
- Product Code
- KWD
- 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 |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | FDA class 2 | Orthopedic |
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Other Clearances by Metasurg
| K Number | Device Name | ||
|---|---|---|---|
| K123926 | METASURG NITINOL STAPLE IMPLANT | May 3, 2013 | Substantially Equivalent |
| K111265 | METASURG SUBTALAR IMPLANT | Aug 9, 2011 | Substantially Equivalent |
| K111536 | METASURG DIGIFUSE IMPLANT | Jul 21, 2011 | Substantially Equivalent |
| K070441 | METASURG SUBTALAR IMPLANT | May 8, 2007 | Substantially Equivalent |