FDA.reportPublic FDA data

ZEUS-L

Primary DI
00840916157685
Brand
ZEUS-L
Company
SPINAL ELEMENTS
Model
16-AU0818LT
Device description
ANGLED LLIF LORDOTIC TRIAL, 08 X 18 MM, UP
Published
2020-05-11
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
00840916157685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916157685008409161576858409161576850840916157685

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
00190776437855MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776437862MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776439873MilleniumAvalign Technologies, Inc.LXH2026-11-04
00810155330057Tigon MedicalTigon Medical LLCLXH2026-11-04
08800308486030INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.LXH2026-11-04
09353903030331OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
00841731133564REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133571REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133601REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133618REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133625REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133632REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133649REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133656REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133670REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133687REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133700REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133731REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
07630699714822Surgical Manual InstrumentMedacta International SALXH2026-11-03
08800424704063VEGA Cervical Screw SystemGS Medical Co., Ltd.LXH2026-11-03
08809974815977Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-11-03
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02