Fuse ULTRA Foot plating System R327045

GUDID B565R3270451

3.5mm 45mm Cannulated Screw self Drill - Tap

CPM MEDICAL CONSULTANTS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDB565R3270451
NIH Device Record Keycf2a46d8-46a9-4964-9768-774135b2308d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuse ULTRA Foot plating System
Version Model NumberR327045
Catalog NumberR327045
Company DUNS017138000
Company NameCPM MEDICAL CONSULTANTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB565R3270451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

[B565R3270451]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-05
Device Publish Date2023-08-28

On-Brand Devices [Fuse ULTRA Foot plating System]

B565R42260XSR1MTP Plate Xtra Small Right
B565R42260XSL1MTP Plate Xtra Small Left
B565R42260SR1MTP Plate Small Right
B565R42260SL1MTP Plate Small Left
B565R42260MR1MTP Plate Medium Right
B565R42260ML1MTP Plate Medium Left
B565R42260LR1MTP Plate Large Right
B565R42260LL1MTP Plate Large Left
B565R42185013.5 mm Non-Locking Screw 50mm
B565R42184513.5 mm Non-Locking Screw 45mm
B565R42184013.5 mm Non-Locking Screw 40mm
B565R42183513.5 mm Non-Locking Screw 35mm
B565R42183013.5 mm Non-Locking Screw 30mm
B565R42182813.5 mm Non-Locking Screw 28mm
B565R42182613.5 mm Non-Locking Screw 26mm
B565R42182413.5 mm Non-Locking Screw 24mm
B565R42182213.5 mm Non-Locking Screw 22mm
B565R42182013.5 mm Non-Locking Screw 20mm
B565R42181813.5 mm Non-Locking Screw 18mm
B565R42181613.5 mm Non-Locking Screw 16mm
B565R42181413.5 mm Non-Locking Screw 14mm
B565R42175013.5mm Locking Screw 50mm
B565R42174513.5mm Locking Screw 45mm
B565R42174013.5mm Locking Screw 40mm
B565R42173513.5mm Locking Screw 35mm
B565R42173013.5mm Locking Screw 30mm
B565R42172813.5mm Locking Screw 28mm
B565R42172613.5mm Locking Screw 26mm
B565R42172413.5mm Locking Screw 24mm
B565R42172213.5mm Locking Screw 22mm
B565R42172013.5mm Locking Screw 20mm
B565R42171813.5mm Locking Screw 18mm
B565R42171613.5mm Locking Screw 16mm
B565R42171413.5mm Locking Screw 14mm
B565R42171213.5mm Locking Screw 12mm
B565R42171013.5mm Locking Screw 10mm
B565R421006R1Lapidus Plate 6.0mm Right
B565R421006L1Lapidus Plate 6.0mm Left
B565R421004R1Lapidus Plate 4.0mm Right
B565R421004L1Lapidus Plate 4.0mm Left
B565R421002R1Lapidus Plate 2.0mm Right
B565R421002L1Lapidus Plate 2.0mm Left
B565R421000R1Lapidus Plate 0.0mm Right
B565R421000L1Lapidus Plate 0.0mm Left
B565R32796014.0mm 60mm Headless Cannulated Screw
B565R32795514.0mm 55mm Headless Cannulated Screw
B565R32795014.0mm 50mm Headless Cannulated Screw
B565R32794514.0mm 45mm Headless Cannulated Screw
B565R32794014.0mm 40mm Headless Cannulated Screw
B565R32793814.0mm 38mm Headless Cannulated Screw
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.