FDA.reportPublic FDA data

ZEUS-L

Primary DI
00840916157586
Brand
ZEUS-L
Company
SPINAL ELEMENTS
Model
16-2105
Device description
LEFT ANGLED PITUITARY, 4MM
Published
2020-05-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840916157586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916157586008409161575868409161575860840916157586

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004022104
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916156176TALONTL22342020-05-05
00840916156183TALONTL22352020-05-05
00840916156190TALONTL22362020-05-05
00840916156206TALONTL22372020-05-05
00840916156213TALONTL22382020-05-05
00840916107208OMNICT050502017-06-19
00840916107215OMNICT050552017-06-19
00840916107253OMNICT060502017-06-19
00840916107291OMNICT070452017-06-19
00840916107307OMNICT070502017-06-19
00840916107987OMNILCPT 100-K2017-06-27
00840916108007OMNILCPT 120-K2017-06-27
00840916108014OMNILCPT 130-K2017-06-27
00840916108021OMNILCPT 140-K2017-06-27
00840916108038OMNILCPT 150-K2017-06-27
00840916108045OMNILCPT 35-K2017-06-28
00840916108052OMNILCPT 40-K2017-06-28
00840916108069OMNILCPT 45-K2017-06-28
00840916108076OMNILCPT 50-K2017-06-28
00840916108083OMNILCPT 55-K2017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894827723AVENGERMedartis AGLXH2026-10-13
07630894827730AVENGERMedartis AGLXH2026-10-13
07630894827747AVENGERMedartis AGLXH2026-10-13
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
00724995225148NASTERIS CORPORATIONLXH2025-03-31
00196449010219A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
00196449012800A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
B0842002000400Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000410Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000420Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000430Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000440Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000450Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000460Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000470Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000480Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000490Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000500Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000600Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000610Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000620Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000630Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000640Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000650Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000660Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000670Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000680Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000690Keos Lumbar InstrumentKEOSLXH2023-02-07