FDA.reportPublic FDA data

Nextra Hammertoe Correction System

Primary DI
00817701020363
Brand
Nextra Hammertoe Correction System
Company
NEXTREMITY SOLUTIONS, INC.
Model
NX-35M
Device description
3.5mm Middle Rescue Implant
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

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122031000NEXTRA TI HAMMERTOE CORRECTION SYSTEMNextremity Solutions, LLC2012-10-09HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817701020363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817701020363008177010203638177010203630817701020363

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.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810082893885Stealthfix Intraosseous Fixation SystemSF3515142022-08-04
00810082893892Stealthfix Intraosseous Fixation SystemSF3515162022-08-04
00810082893908Stealthfix Intraosseous Fixation SystemSF3515182022-08-04
00810082893915Stealthfix Intraosseous Fixation SystemSF3515202022-08-04
00810082893922Stealthfix Intraosseous Fixation SystemSF4515142022-08-04
00810082893939Stealthfix Intraosseous Fixation SystemSF4515162022-08-04
00810082893946Stealthfix Intraosseous Fixation SystemSF4515182022-08-04
00810082893953Stealthfix Intraosseous Fixation SystemSF4515202022-08-04
00810082893960Stealthfix Intraosseous Fixation SystemSF4515222022-08-04
00810082893977Stealthfix Intraosseous Fixation SystemSF4515242022-08-04
00810082893984Stealthfix Intraosseous Fixation SystemSF4515262022-08-04
00810082893991Stealthfix Intraosseous Fixation SystemSF4515282022-08-04
00810082894004Stealthfix Intraosseous Fixation SystemSF4515302022-08-04
00810082894011Stealthfix Intraosseous Fixation SystemSF4515322022-08-04
00810082894028Stealthfix Intraosseous Fixation SystemSF4520142022-08-04
00810082894035Stealthfix Intraosseous Fixation SystemSF4520162022-08-04
00810082894042Stealthfix Intraosseous Fixation SystemSF4520182022-08-04
00810082894059Stealthfix Intraosseous Fixation SystemSF4520202022-08-04
00810082894066Stealthfix Intraosseous Fixation SystemSF4520222022-08-04
00810082894073Stealthfix Intraosseous Fixation SystemSF4520242022-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532014Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10