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

CROSS PIN

K Number: K961920 · Decision Sep 17, 1996
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
8
Review Days
123

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Basic Information

Device Name
CROSS PIN
K Number
K961920
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.3040
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Medicinelodge, Inc.
Date Received
May 17, 1996
Decision Date
September 17, 1996
Product Code
JDW
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
JDW Pin, Fixation, Threaded

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K Number Device Name
K072525 ZIPKNOT, MODEL 1017-3000
K051488 MEDICINELODGE ZIPKNOT
K962705 MLI MODULAR STAPLE
K961905 MEDICINELODGE, INC. SET SCREW
K962194 MLI SOFT TISSUE SCREW & WASHER SYSTEM
K961025 EXPANDED BODY SUTURE
K953350 MLI INTERFERENCE SCREW