FDA.report

Nextra Hammertoe Correction System

Primary DI
00817701020035
Brand
Nextra Hammertoe Correction System
Company
NEXTREMITY SOLUTIONS, INC.
Model
NX-32K-SC
Device description
3.2 Proximal Saw Cut
Published
2016-09-26
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

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K122031000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K122031000NEXTRA TI HAMMERTOE CORRECTION SYSTEMNextremity Solutions, LLC2012-10-09HWC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817701020035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817701020035008177010200358177010200350817701020035

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
060783407
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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