FDA.reportPublic FDA data

L-Varlock

Primary DI
00850011324141
Brand
L-Varlock
Company
SPINESOURCE INC
Model
141
Catalog number
HD0064
Device description
Instrument, Inserter
Published
2020-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011324141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011324141008500113241418500113241410850011324141

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
150955560
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011324158L-Varlock158VAL-CA-13-092021-06-03
00850011324165L-Varlock165VAL-CA-13-112021-06-03
00850011324134L-Varlock134VAL-CA-13-132020-11-24
00850011324028L-Varlock028DS-1072019-08-22
00850011324035L-Varlock035DS-1082019-08-22
00850011324042L-Varlock042DS-1092019-08-22
00850011324059L-Varlock059DS-1102019-08-22
00850011324066L-Varlock066DS-1112019-08-22
00850011324073L-Varlock073DS-1122019-08-22
00850011324080L-Varlock080DS-1132019-08-22
00850011324127L-Varlock127SP-0022020-01-22
00850011324110L-Varlock110VAL-CA-10-092019-11-12
00850011324097L-Varlock097SD-41002019-10-11
00850011324103L-Varlock103HA-0022019-10-11
00850011324004L-Varlock004VAL-CA-13-082019-08-15
00850011324011L-Varlock011SP-0012019-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867550292Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550308Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550315Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550322Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550339Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550346Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550353Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550360Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550377Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550384Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552692Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552708Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552715Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552722Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552739Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552746Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552753Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552760Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574564Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574571Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574588Arthrex®ARTHREX, INC.LXH2026-09-18
04054896000831Control GaugesSilony Medical GmbHLXH2026-09-18
04054896000855Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000862Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000879Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000886Forceps and ClampsSilony Medical GmbHLXH2026-09-18
04054896000893(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000909(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000916(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000923AdapterSilony Medical GmbHLXH2026-09-18