FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRAFTCAGE ACX
K Number: K053080
·
Decision Dec 1, 2005
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
24
Review Days
29
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Basic Information
- Device Name
- GRAFTCAGE ACX
- K Number
- K053080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteotech, Inc.
- Date Received
- November 2, 2005
- Decision Date
- December 1, 2005
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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Other Clearances by Osteotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES | Oct 16, 2008 | Substantially Equivalent |
| K081227 | PLEXUR M | Jul 22, 2008 | Substantially Equivalent |
| K080511 | PLEXUR-P | Apr 21, 2008 | Substantially Equivalent |
| K073405 | PLEXUR M | Mar 3, 2008 | Substantially Equivalent |
| K061982 | PLEXUR P | Feb 7, 2007 | Substantially Equivalent |
| K051188 | GRAFTON DBM | Jan 3, 2006 | Substantially Equivalent |
| K051781 | GRAFTCAGE TLX | Dec 16, 2005 | Substantially Equivalent |
| K051195 | GRAFTON DBM | Dec 16, 2005 | Substantially Equivalent |
| K043209 | VIAGRAF DBM PASTE | Dec 5, 2005 | Substantially Equivalent |
| K042707 | GRAFTON PLUS DBM PASTE | Nov 30, 2005 | Substantially Equivalent |