FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
K Number: K060987
·
Decision Nov 2, 2006
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
31
Review Days
206
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
- K Number
- K060987
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cp Medical
- Date Received
- April 10, 2006
- Decision Date
- November 2, 2006
- Product Code
- MTJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MTJ | Wax, Bone | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MTJ), ordered by most recent decision date.
Permatage Flowable, Settable Hemostatic Bone Paste
FDA 510(k)
FDA Unclassified
·Unknown
Montage- XT Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
MONTAGE Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
FDA 510(k)
FDA Unclassified
·Unknown
Meril-Bonewax
FDA 510(k)
FDA Unclassified
·Unknown
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Cp Medical
| K Number | Device Name | ||
|---|---|---|---|
| K094028 | CP-FIBER (ORTHOFIBER) | Mar 18, 2010 | Substantially Equivalent |
| K072229 | MONOSWIFT | Oct 5, 2007 | Substantially Equivalent |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | Jul 18, 2007 | Substantially Equivalent |
| K041894 | ORTHOFIBER | Sep 17, 2004 | Substantially Equivalent |
| K034062 | CP SLEEVE AND RIVER SLEEVE | Jan 30, 2004 | Substantially Equivalent |
| K024372 | CP MEDICAL BONE WAX | Jun 19, 2003 | Substantially Equivalent |
| K030786 | MONO-SWIFT | May 6, 2003 | Substantially Equivalent |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Mar 28, 2003 | Substantially Equivalent |
| K023710 | VISORB SWIFT | Jan 17, 2003 | Substantially Equivalent |
| K022075 | DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 | Sep 19, 2002 | Substantially Equivalent |