FDA.reportPublic FDA data

FREE GLIDING SCFE SCREW SYSTEM

Primary DI
07540194007889
Brand
FREE GLIDING SCFE SCREW SYSTEM
Company
Orthopediatrics Canada ULC
Model
SCF-KNB265
Catalog number
SCF-KNB265
Device description
SCFE DRIVER KNOB SUBASSY Ø6.5mm - MINI
Published
2020-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194007889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194007889075401940078897540194007889

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(450)688-5144egarcia@pegamedical.com

Regulatory Flags#

DUNS number
243298854
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540194018168Dr.Paleys Osteotomy SystemDRPO-706DRPO-7062026-03-11
07540194013163The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-IMP100-CPOP-IMP100-C2021-11-30
07540194008916The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-CAP100POP-CAP1002020-08-12
07540194009067The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-IMP100POP-IMP1002020-08-12
07540194002181GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP015GAP-CP0152016-10-20
07540194002198GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP050GAP-CP0502016-10-20
07540194002204GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP100GAP-CP1002016-10-20
07540194002396FREE GLIDING SCFE SCREW SYSTEMSCF-MC-065SCF-MC-0652016-10-20
07540194002570FREE GLIDING SCFE SCREW SYSTEMSCF-MC-073SCF-MC-0732016-10-20
07540194004215SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-315SLM-CAP-3152016-10-20
07540194004222SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-350SLM-CAP-3502016-10-20
07540194004239SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-415SLM-CAP-4152016-10-20
07540194004246SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-450SLM-CAP-4502016-10-20
07540194009982GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360-PKG2GAP-KDG360-PKG22020-08-12
07540194009999GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360-PKG6GAP-KDG360-PKG62020-08-12
07540194016737GAP ENDO-EXO MEDULLARY SYSTEMGAP-SDG200GAP-SDG2002024-06-13
07540194009975GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360GAP-KDG3602020-08-12
07540194017956GIRO GROWTH MODULATION SYSTEMGRO-CYF250-35GRO-CYF250-352025-03-31
07540194015907HINGE PEDIATRIC PLATING SYSTEMHP-CYF250HP-CYF2502024-09-11
07540194015921GIRO GROWTH MODULATION SYSTEMGRO-CYF150-45GRO-CYF150-452024-09-11

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