FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Bone Void, Non-Osteoinduction
PMA: P860005
·
Supplement: S011
·
Decision May 25, 1999
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Filler, Bone Void, Non-Osteoinduction
- Trade Name
- PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES
- PMA Number
- P860005
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- MBS
- Generic Name
- Filler, bone void, non-osteoinduction
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 25, 1999
- Date Received
- April 22, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for updated labeling that reflects the results of the completed post-market approval study.
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 |