Atlas FDA

MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA

FDA 510(k) clearance K002324 · decided 2000-08-24

Clearance details

K-number
K002324
Device name
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
Applicant
Sulzermedica
Decision
Substantially Equivalent
Date received
2000-07-31
Decision date
2000-08-24
Days to decision
24 days
Clearance type
Special
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Austin, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitat recall (Z-0861-2012)Zimmer Inc.2012-01-25

PMA approvals by this applicant

RecordFirmDate
NATURAL-KNEE AND NATURAL-KNEE II (P940002/S005)Sulzermedica2001-08-01
NATURAL KNEE & NATURAL KNEE II (P940002/S003)Sulzermedica2000-04-18
NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S002)Sulzermedica1997-10-16
NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S001)Sulzermedica1997-04-30
NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM) (P940002)Sulzermedica1997-03-21