FDA.report

Nextra Hammertoe Correction System

Primary DI
00817701020417
Brand
Nextra Hammertoe Correction System
Company
NEXTREMITY SOLUTIONS, INC.
Model
NX-GRA
Device description
Grasper Surgical Tool
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions

SubmissionSupplement
K122031000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817701020417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817701020417008177010204178177010204170817701020417

GMDN Terms

TermDefinition
Orthopaedic implant/trial-implant holder, single-useA sterile hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a single-use device.

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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00810082893984Stealthfix Intraosseous Fixation SystemSF4515262022-08-04
00810082893991Stealthfix Intraosseous Fixation SystemSF4515282022-08-04
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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
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00810082894073Stealthfix Intraosseous Fixation SystemSF4520242022-08-04

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