FDA.reportPublic FDA data

LexTORNADO

Primary DI
04589761818018
Brand
LexTORNADO
Company
MEDMETALEX CO., LTD.
Model
MUA00052
Catalog number
MUA00052
Device description
LexTORNADO Femoral Head Extractor Connect Type, Zimmer End
Published
2023-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589761818018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589761818018045897618180184589761818018

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
718085432
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
04589761815826LexCALIPERMUA00050MUA000502023-03-31
04589761818001LexTORNADOMUA00051MUA000512023-10-02
04589761815789LexTOMEMUA00046MUA000462023-04-24
04589761818025LexBLADEMUA00053MUA000532023-10-02
04589761818032LexBLADEMUA00054MUA000542023-10-02
04589761818049LexBLADEMUA00055MUA000552023-10-02
04589761818056LexBLADEMUA00056MUA000562023-10-02
04589761818063LexBLADEMUA00057MUA000572023-10-02
04589761818070LexBLADEMUA00058MUA000582023-10-02
04589761818087LexBLADEMUA00059MUA000592023-10-02
04589761818094LexBLADEMUA00060MUA000602023-10-02
04589761818100LexBLADEMUA00061MUA000612023-10-02
04589761818117LexBLADEMUA00062MUA000622023-10-02
04589761818124LexBLADEMUA00063MUA000632023-10-02
04589761818131LexBLADEMUA00064MUA000642023-10-02
04589761818346quick armMUA00065MUA000652023-10-02
04589761818353quick armMUA00066MUA000662023-10-02
04589761818360quick armMUA00067MUA000672023-10-02
04589761818377quick armMUA00068MUA000682023-10-02
04589761818384quick arm MUA00069MUA000692023-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433598MillenniumAvalign Technologies, Inc.HWB2026-10-06
00190776432751MillenniumAvalign Technologies, Inc.HWB2026-09-29
00810017915828SABER-XA, Simultaneous ExpanderELEVATION SPINE, INC.HWB2026-09-21
00810017915804SABER-XA, Height ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915811SABER-XA, Lordosis ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915958Slap HammerELEVATION SPINE, INC.HWB2026-08-14
00810017915965Slap Hammer AdaptorELEVATION SPINE, INC.HWB2026-08-14
03701089527965AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089527972AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089531276AMPLITUDEAMPLITUDE SASHWB2026-07-29
00889024711495Z1 ExtractorZimmer, Inc.HWB2026-07-20
08800068946966BENCOXCorentec Co., LtdHWB2026-07-01
08800068946973BENCOXCorentec Co., LtdHWB2026-07-01
08800068963666BENCOXCorentec Co., LtdHWB2026-07-01
08806373897344BENCOXCorentec Co., LtdHWB2026-07-01
08806373897351BENCOXCorentec Co., LtdHWB2026-07-01
08806373897368BENCOXCorentec Co., LtdHWB2026-07-01
08806373897375BENCOXCorentec Co., LtdHWB2026-07-01
08806373897382BENCOXCorentec Co., LtdHWB2026-07-01
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00810135963411ImpactNVision Biomedical Technologies, Inc.HWB2025-09-24
00840314269737gSourceGSOURCE LLCHWB2025-05-05
00810112598070MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHWB2024-07-31
00810112596250TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWB2024-02-23
00885556820964General InstrumentsSmith & Nephew, Inc.HWB2023-10-27
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
00818069011055TecometTECOMET INC.HWB2023-08-10
00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10