FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MECRON CANCELLOUS CANNULATED BONE SCREWS

K Number: K810205 · Decision Feb 9, 1981
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
6
Review Days
14

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
MECRON CANCELLOUS CANNULATED BONE SCREWS
K Number
K810205
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.3040
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Serrano Intl.
Date Received
January 26, 1981
Decision Date
February 9, 1981
Product Code
HWC
Advisory Committee
Orthopedic
Review Advisory Committee
OR
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HWC Screw, Fixation, Bone

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (HWC), ordered by most recent decision date.

View all

Other Clearances by Serrano Intl.

K Number Device Name
K851409 UNILOC TOTAL HIP PROSTHESIS
K820619 MECRON(R) ACETABULAR NETS TM
K820899 MECRON VOORHOEVE TITANIUM SHEATH
K820852 MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY
K810497 BONE FIXACTION SCREW