FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONNEXUS, .5CC, MODEL 023000-005
K Number: K052098
·
Decision Sep 7, 2005
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
10
Review Days
35
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Basic Information
- Device Name
- CONNEXUS, .5CC, MODEL 023000-005
- K Number
- K052098
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isotis Orthobiologics, Inc.
- Date Received
- August 3, 2005
- Decision Date
- September 7, 2005
- Product Code
- MQV
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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Other Clearances by Isotis Orthobiologics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091193 | ACCELL EVO3C | Aug 10, 2009 | Substantially Equivalent |
| K081817 | ACCELL TBM-R | Sep 24, 2008 | Substantially Equivalent |
| K070751 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Oct 15, 2007 | Substantially Equivalent |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | Dec 5, 2005 | Substantially Equivalent |
| K043573 | DYNAGRAFT II DENTAL | Jul 29, 2005 | Substantially Equivalent |
| K050690 | CONNEXUS | Jul 7, 2005 | Substantially Equivalent |
| K040419 | DYNAGRAFT II | Mar 25, 2005 | Substantially Equivalent |
| K042706 | OSSATURA DENTAL | Oct 20, 2004 | Substantially Equivalent |
| K041991 | ASPIREX - BONE MARROW ASPIRATE KIT | Sep 16, 2004 | Substantially Equivalent |