SYMMETRY MEDICAL INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopedic Manual Surgical Instrument (LXH) (5) Catheter And Tip, Suction (JOL) (2) Osteotome, Manual (GFI) (2) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

GLOBAL UNITE™ Short Stem Instrumentation - 00817766026423 Catalog Number :

Device Description : SHORT HUMERAL CASE

Device Class : 2

Duns Number: 079881212

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

Suction Tube, 11 Fr, 90° angle, 177mm shaft (with stylet) - 00847538000023 Catalog Number : 74-755-000

Device Class : 2

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Suction Tube, 11 Fr, 90° angle, 118mm shaft (with stylet) - 00847538000030 Catalog Number : 74-756-000

Device Class : 2

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 8mm X 3” - 00847538000986 Catalog Number : 00-9986-021-20

Device Description : Thin Osteotome Blade, 8mm X 3”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 8mm X 3” - 00847538000993 Catalog Number : 2709-04-004;47-9986-021-20

Device Description : Thin Osteotome Blade, 8mm X 3”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Flag Splitter - 00847538001006 Catalog Number : 00-9986-010-12;430001

Device Description : Flag Splitter

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

“V” Splitter - 00847538001013 Catalog Number : 00-9986-010-13;430002

Device Description : “V” Splitter

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Chisel, 8mm - 00847538001020 Catalog Number : 00-9986-010-14;430003

Device Description : Chisel, 8mm

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Straight Gouge - 00847538001044 Catalog Number : 00-9986-010-16;430005

Device Description : Straight Gouge

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Quick-Coupling Handle for Flexible Osteotomes - 00847538001051 Catalog Number : 2709-04-001

Device Description : Quick-Coupling Handle for Flexible Osteotomes

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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