FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

Bone Cement

PMA: N17755 · Decision May 17, 1976
Classifications
1
FEI Numbers
81
Registration Numbers
81

Basic Information

Device Name
Bone Cement
Trade Name
ZIMMER(R) BONE CEMENT
PMA Number
N17755
Device Class
FDA Class 2
Product Code
LOD
Generic Name
BONE CEMENT
Regulation Number
888.3027
Medical Specialty
Orthopedic
Advisory Committee
Orthopedic
Decision
Approved (Reclassification)
Decision Code
APRL
Decision Date
May 17, 1976
Date Received
May 17, 1976
Expedited Review
N

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LOD Bone Cement