510(k) K941605

STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH by Stryker Corp. — Product Code LXH

K941605 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH". The FDA issued a decision of Substantially Equivalent on August 5, 1994. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Stryker Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
April 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type