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

Osteotome, Manual (GFI) (9) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Small Slap Hammer - 00847538001068 Catalog Number : 2709-04-002;00-9986-021-11;430022

Device Description : Small Slap Hammer

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 10mm X 3” - 00847538001075 Catalog Number : 00-9986-021-21

Device Description : Thin Osteotome Blade, 10mm X 3”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 12mm X 3” - 00847538001082 Catalog Number : 00-9986-021-22

Device Description : Thin Osteotome Blade, 12mm X 3”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 20mm X 3” - 00847538001099 Catalog Number : 00-9986-021-23

Device Description : Thin Osteotome Blade, 20mm X 3”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade curve end 12mm - 00847538001105 Catalog Number : 00-9986-021-24

Device Description : Thin Osteotome Blade curve end 12mm

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade curve end 20mm - 00847538001112 Catalog Number : 00-9986-021-25

Device Description : Thin Osteotome Blade curve end 20mm

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 10mm X 5” - 00847538001129 Catalog Number : 00-9986-021-26

Device Description : Thin Osteotome Blade, 10mm X 5”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 8mm X 5” - 00847538001136 Catalog Number : 00-9986-021-27

Device Description : Thin Osteotome Blade, 8mm X 5”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 10mm X 3” - 00847538001143 Catalog Number : 2709-04-005;47-9986-021-21

Device Description : Thin Osteotome Blade, 10mm X 3”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Thin Osteotome Blade, 12mm X 3” - 00847538001150 Catalog Number : 2709-04-006;47-9986-021-22

Device Description : Thin Osteotome Blade, 12mm X 3”

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

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