FDA.reportPublic FDA data

NA

Primary DI
20705034764051
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
292.020
Catalog number
292020
Device description
1.25MM GUIDE WIRE 200MM
Published
2019-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRNWire, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRNWire, SurgicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705034764051PrimaryGS10
H9812920200SecondaryHIBCC0
80705034764053Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503476405120705034764051
8070503476405380705034764053

GMDN Terms#

Term, Definition table
TermDefinition
Spinal guidewireA thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14
10886982064745NA03.000.066S03000066S2016-06-30
10886982064820NA03.000.079S03000079S2016-06-30
10886982064844NA03.000.082S03000082S2016-06-30
10886982064882NA03.000.097S03000097S2016-06-30
10886982064905NA03.000.100S03000100S2016-06-30
10886982064929NA03.000.104S03000104S2016-06-30
10886982064936NA03.000.106S03000106S2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124516496FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124516502FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124517509FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124517516FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124518551FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124524712FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-11-03
00840124521599FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-09-17
00840124521674FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-09-17
00840124514843FuzeRightFUSION ORTHOPEDICS, LLCLRN2025-01-07
00840124514782LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514799LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514805LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514812LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514829LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514836LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00673978047690ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2021-12-19
M20922794K-Wire with stop 1.0mmBIOPRO, INC.LRN2020-08-05
H9812920200NASYNTHES (U.S.A.) LPLRN2019-08-29
10603295210320NADEPUY INTERNATIONAL LTDLRN2018-09-24
00889024035546NAZimmer, Inc.LRN2017-09-26
M209206660K-Wire with stop 1.0mmBIOPRO, INC.LRN2017-08-13
10603295067740CONTROLDEPUY ORTHOPAEDICS, INC.LRN2017-07-21
20673978047885ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
20673978047977ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
20673978048004ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
04546540568083Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568090Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568106Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568113Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568120Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24