SambaScrew

GUDID 18257200119172

9mm x 25mm SambaScrew

ORTHOFIX INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

Primary Device ID	18257200119172
NIH Device Record Key	c72d44fc-72d2-4c3e-9dcf-5fdcfb466447
Commercial Distribution Status	In Commercial Distribution
Brand Name	SambaScrew
Version Model Number	11-1109-1
Company DUNS	927083808
Company Name	ORTHOFIX INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter
Width	9 Millimeter
Length	25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200119172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121148

FDA Product Code

HWC	Screw, Fixation, Bone