FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Bone Void, Non-Osteoinduction
PMA: P860005
·
Supplement: S008
·
Decision Sep 11, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Filler, Bone Void, Non-Osteoinduction
- Trade Name
- PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)
- PMA Number
- P860005
- Supplement Number
- S008
- 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
- September 11, 1997
- Date Received
- August 28, 1997
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for a new sterilization site located at Isomedix Operations, Inc., Sand Utah Division, 9120 South 150 East, Sandy, UT.
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 |