HNM STUCKENBROCK, 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

Plate, Fixation, Bone (HRS) (10)

Premarket Exempt

Clear

IXOS - 00850005146001 Catalog Number : HS-26-905-08-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)8mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146018 Catalog Number : HS-26-905-09-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)9mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146025 Catalog Number : HS-26-905-10-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)10mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146032 Catalog Number : HS-26-905-11-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)11mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146049 Catalog Number : HS-26-905-12-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)12mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146056 Catalog Number : HS-26-905-13-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)13mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146063 Catalog Number : HS-26-905-14-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)14mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146070 Catalog Number : HS-26-905-15-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)15mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146087 Catalog Number : HS-26-905-16-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)16mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146094 Catalog Number : HS-26-905-17-09

Device Description : smartDrive ø2.5mm LOCKING SCREW (L)17mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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