FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Filler, Bone Void, Non-Osteoinduction
PMA: P900039
·
Supplement: S015
·
Decision Jan 24, 2005
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Filler, Bone Void, Non-Osteoinduction
- Trade Name
- COLLAGRAFT STRIP BONE GRAFT MATRIX
- PMA Number
- P900039
- Supplement Number
- S015
- Device Class
- FDA Class 3
- Product Code
- MBS
- Generic Name
- Filler, bone void, non-osteoinduction
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 24, 2005
- Date Received
- December 27, 2004
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGE IN THE FINAL PRODUCT TESTING FROM RABBIT PYROGENICITY TEST TO A LIMULUS AMEBOCYTE LYSATE (LAL) GEL-CLOT TEST FOR DETERMINING THE PRESENCE OF ENDOTOXINS.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MBS | Filler, Bone Void, Non-Osteoinduction | FDA class 3 | Unknown |