HNM STUCKENBROCK, INC.

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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 - 00850005146308 Catalog Number : HS-26-906-20-09

Device Description : smartDrive ø2.5mm STANDARD SCREW, (L)20mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146315 Catalog Number : HS-26-906-22-09

Device Description : smartDrive ø2.5mm STANDARD SCREW, (L)22mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146322 Catalog Number : HS-26-906-24-09

Device Description : smartDrive ø2.5mm STANDARD SCREW, (L)24mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146339 Catalog Number : HS-26-906-26-09

Device Description : smartDrive ø2.5mm STANDARD SCREW, (L)26mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146346 Catalog Number : HS-26-906-28-09

Device Description : smartDrive ø2.5mm STANDARD SCREW, (L)28mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146353 Catalog Number : HS-26-906-30-09

Device Description : smartDrive ø2.5mm STANDARD SCREW, (L)30mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146360 Catalog Number : HS-26-907-14-09

Device Description : smartDrive ø2.0mm LOCKING PIN, (L)14mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146377 Catalog Number : HS-26-907-15-09

Device Description : smartDrive ø2.0mm LOCKING PIN, (L)15mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146384 Catalog Number : HS-26-907-16-09

Device Description : smartDrive ø2.0mm LOCKING PIN, (L)16mm, TI

Device Class : 2

Duns Number: 117068079

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

IXOS - 00850005146391 Catalog Number : HS-26-907-17-09

Device Description : smartDrive ø2.0mm LOCKING PIN, (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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