FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHUTTLE STOP
K Number: K000587
·
Decision May 4, 2000
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
8
Review Days
72
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Basic Information
- Device Name
- SHUTTLE STOP
- K Number
- K000587
- 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
- Isotis NV
- Date Received
- February 22, 2000
- Decision Date
- May 4, 2000
- Product Code
- LZN
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LZN | Cement Obturator | FDA class 2 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
| K061880 | ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC | Aug 15, 2007 | Substantially Equivalent |
| K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Mar 29, 2006 | Substantially Equivalent |
| K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | Mar 27, 2006 | Substantially Equivalent |
| K031813 | OSSATURA DENTAL | Aug 20, 2004 | Substantially Equivalent |
| K041344 | OPEN BORE SYRINGE | Jul 16, 2004 | Substantially Equivalent |
| K030131 | OSSATURA BCP BONE VOID FILLER | May 20, 2003 | Substantially Equivalent |
| K010840 | SYNPLUG | Apr 20, 2001 | Substantially Equivalent |