FDA.report

Re+Line Bunion Correction System

Primary DI
00817701020844
Brand
Re+Line Bunion Correction System
Company
NEXTREMITY SOLUTIONS, INC.
Model
RS-DR
Device description
Re+Line Driver
Published
2017-06-12
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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817701020844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817701020844008177010208448177010208440817701020844

GMDN Terms

TermDefinition
Surgical screwdriver, single-use, sterileA sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. 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
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19
07630542789984Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542789991Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542797576Surgical Manual InstrumentMedacta International SALXH2026-03-19