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

Trephine (HWK) (9) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

T-Bar Stem Extractor - 00847538001471 Catalog Number : 2709-05-003;00-9986-040-12

Device Description : T-Bar Stem Extractor

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Wrench - 00847538001488 Catalog Number : 2709-05-004;00-9986-040-13

Device Description : Wrench

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

Trephine 11mm ID - 00847538001495 Catalog Number : 2709-05-110;00-9986-040-14

Device Description : Trephine 11mm ID

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

Trephine 11.5mm ID - 00847538001501 Catalog Number : 2709-05-115;00-9986-040-15

Device Description : Trephine 11.5mm ID

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

Trephine 12mm ID - 00847538001518 Catalog Number : 2709-05-120;00-9986-040-16

Device Description : Trephine 12mm ID

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

Trephine 12.5mm ID - 00847538001525 Catalog Number : 2709-05-125;00-9986-040-17

Device Description : Trephine 12.5mm ID

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

Trephine 13mm ID - 00847538001532 Catalog Number : 2709-05-130;2709-05-130

Device Description : Trephine 13mm ID

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

Trephine 13.5mm ID - 00847538001549 Catalog Number : 2709-05-135;00-9986-040-19

Device Description : Trephine 13.5mm ID

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

Trephine 14mm ID - 00847538001556 Catalog Number : 2709-05-140;00-9986-040-20

Device Description : Trephine 14mm ID

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

Trephine 14.5mm ID - 00847538001563 Catalog Number : 2709-05-145;00-9986-040-21

Device Description : Trephine 14.5mm ID

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWK

Prescription Use : Yes

Device Count : 1

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