FDA.report

Apex

Primary DI
05391529583545
Brand
Apex
Company
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Model
LS02-60040
Catalog number
LS02-60040
Device description
Locking Screw Ø6 x 40mm
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05391529583545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05391529583545053915295835455391529583545

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Ambient Storage and Handling

Sterilization Methods

Method

Contacts

PhoneEmail
646-661-3167customercare@orthoxel.com

Regulatory Flags

DUNS number
985596830
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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05391543064273ApexINS-1191INS-11912023-07-11
05391529587970ApexF05-100460F05-1004602023-07-10
05391529587987ApexF05-110240F05-1102402023-07-10
05391529587994ApexF05-110260F05-1102602023-07-10
05391529588007ApexF05-110280F05-1102802023-07-10
05391529588014ApexF05-110300F05-1103002023-07-10
05391529588021ApexF05-110320F05-1103202023-07-10
05391529588038ApexF05-110340F05-1103402023-07-10
05391529588045ApexF05-110360F05-1103602023-07-10
05391529588052ApexF05-110380F05-1103802023-07-10
05391529588069ApexF05-110400F05-1104002023-07-10
05391529588076ApexF05-110420F05-1104202023-07-10
05391529588083ApexF05-110440F05-1104402023-07-10
05391529588090ApexF05-110460F05-1104602023-07-10
05391529588106ApexF05-115240F05-1152402023-07-10
05391529588113ApexF05-115260F05-1152602023-07-10
05391529588120ApexF05-115280F05-1152802023-07-10
05391529588137ApexF05-115300F05-1153002023-07-10

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