FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIPKNOT, MODEL 1017-3000
K Number: K072525
·
Decision Oct 5, 2007
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- ZIPKNOT, MODEL 1017-3000
- K Number
- K072525
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medicinelodge, Inc.
- Date Received
- September 7, 2007
- Decision Date
- October 5, 2007
- Product Code
- FZP
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medicinelodge, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051488 | MEDICINELODGE ZIPKNOT | Jul 27, 2005 | Substantially Equivalent |
| K962705 | MLI MODULAR STAPLE | Oct 1, 1996 | Substantially Equivalent |
| K961920 | CROSS PIN | Sep 17, 1996 | Substantially Equivalent |
| K961905 | MEDICINELODGE, INC. SET SCREW | Aug 6, 1996 | Substantially Equivalent |
| K962194 | MLI SOFT TISSUE SCREW & WASHER SYSTEM | Jul 30, 1996 | Substantially Equivalent |
| K961025 | EXPANDED BODY SUTURE | Apr 15, 1996 | Substantially Equivalent for Some Indications |
| K953350 | MLI INTERFERENCE SCREW | Jan 30, 1996 | Substantially Equivalent for Some Indications |