Materialise USA LLC

Lot #154970

Orthopedic Devices

2

Yes

One consignee, Indiana.

Signature TKA GDE/MDL Set 04-05 || Patient-specific surgical guide and instrument set.

Lot 56529819, REF 005970-000-02 Exp 2012-09-06

Orthopedic Devices

2

Yes

Nationwide Distribution including the states of Ohio and Minnesota.

PATIENT SPECIFIC INSTRUMENTS || LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) || NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE || Patient ID--0242-LF || Manufactured by Materialise, Plymouth, MI || Distributed by Zimmer, Warsaw IN. || Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.

Lot 56529886, REF 005970-000-03 Exp 2012-09-08

Orthopedic Devices

2

Yes

Nationwide Distribution including the states of Ohio and Minnesota.

PATIENT SPECIFIC INSTRUMENTS || N-K FLEX PIN GUIDES (FEMUR AND TIBIA) || NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE || Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI || Distributed by Zimmer, Warsaw IN. || Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.

Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01

Distributed in Canada.

ProPlan CMF Guide(s) Model(s) || REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. || Used as surgical tools to transfer a pre-operative plan to surgery.

Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2

Distributed in Canada.

ProPlan CMF Guide(s) Model(s) || REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. || Used as surgical tools to transfer a pre-operative plan to surgery. || .