HA Coated S-Core Implant

GUDID 10850017962207

HA Coated 10 mm x 10 mm S-Core Implant

SUBCHONDRAL SOLUTIONS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID10850017962207
NIH Device Record Keyf4775e9f-293b-4eea-bef6-921c3b392e58
Commercial Distribution StatusIn Commercial Distribution
Brand NameHA Coated S-Core Implant
Version Model Number20-1000-01-P
Company DUNS117417828
Company NameSUBCHONDRAL SOLUTIONS, INC.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter
Height10 Millimeter
Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017962200 [Primary]
GS110850017962207 [Package]
Contains: 00850017962200
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-30
Device Publish Date2020-10-22

On-Brand Devices [HA Coated S-Core Implant]

10850017962207HA Coated 10 mm x 10 mm S-Core Implant
10850017962191HA Coated 9 mm x 9.5 mm S-Core Implant
10850017962184HA Coated 8 mm x 9 mm S-Core Implant
10850017962177HA Coated 7 mm x 8.5 mm S-Core Implant
10850017962160HA Coated 6 mm x 8 mm S-Core Implant
10850017962153HA Coated 5 mm x 7.5 mm S-Core Implant
10850017962146HA Coated 4 mm x 7 mm S-Core Implant

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