FDA.reportPublic FDA data

Fixion Nailing System

Primary DI
07290109331751
Brand
Fixion Nailing System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Proximal Femur Hip Pin
Catalog number
4405060
Device description
Hip pin used with the Fixion proximal femur intramedullary nail (intended for use in the fixation of proximal fractures in the femur).
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109331751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109331751072901093317517290109331751

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649185170
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117356876CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40122026-03-23
17290117356880CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40142026-03-23
17290117356897CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40162026-03-23
07290117354759CarboClear X Pedicle Screw SystemScrew BlockPPS9221062026-02-25
07290117358436CarboClear Pedicle Screw SystemsCleaning Tip90180CT2026-02-25
17290117358792CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5025C2026-02-08
17290117358808CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5030C2026-02-08
17290117358815CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5035C2026-02-08
17290117358822CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5040C2026-02-08
17290117358839CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5045C2026-02-08
17290117358846CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5530C2026-02-08
17290117358853CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5535C2026-02-08
17290117358860CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5540C2026-02-08
17290117358877CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT5545C2026-02-08
17290117358884CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT6530C2026-02-08
17290117358891CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT6535C2026-02-08
17290117358907CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT6540C2026-02-08
17290117358914CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT6545C2026-02-08
17290117358921CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT6550C2026-02-08
17290117358938CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw MDT6555C2026-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868150876Affixus®Zimmer, Inc.HSB2026-03-20
00887868150333Affixus®Zimmer, Inc.HSB2026-03-19
00887868150340Affixus®Zimmer, Inc.HSB2026-03-19
00887868150357Affixus®Zimmer, Inc.HSB2026-03-19
00887868150364Affixus®Zimmer, Inc.HSB2026-03-19
00887868150371Affixus®Zimmer, Inc.HSB2026-03-19
00887868150388Affixus®Zimmer, Inc.HSB2026-03-19
00887868150395Affixus®Zimmer, Inc.HSB2026-03-19
00887868150401Affixus®Zimmer, Inc.HSB2026-03-19
00887868150555Affixus®Zimmer, Inc.HSB2026-03-19
00887868150562Affixus®Zimmer, Inc.HSB2026-03-19
00887868150579Affixus®Zimmer, Inc.HSB2026-03-19
00887868150586Affixus®Zimmer, Inc.HSB2026-03-19
00887868150593Affixus®Zimmer, Inc.HSB2026-03-19
00887868150609Affixus®Zimmer, Inc.HSB2026-03-19
00887868150616Affixus®Zimmer, Inc.HSB2026-03-19
00887868150883Affixus®Zimmer, Inc.HSB2026-03-19
00887868150890Affixus®Zimmer, Inc.HSB2026-03-19
00887868150906Affixus®Zimmer, Inc.HSB2026-03-19
00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
00887868150920Affixus®Zimmer, Inc.HSB2026-03-19
00889024700253Affixus®Zimmer, Inc.HSB2026-03-19
00889024700260Affixus®Zimmer, Inc.HSB2026-03-19
00889024700277Affixus®Zimmer, Inc.HSB2026-03-19
00889024700284Affixus®Zimmer, Inc.HSB2026-03-19
00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529076Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529137Arthrex®ARTHREX, INC.HSB2026-03-16