FDA.reportPublic FDA data

KARMA MIS

Primary DI
00840606167956
Brand
KARMA MIS
Company
SPINAL ELEMENTS, INC.
Model
75695-000
Device description
Karma Tensioner
Published
2022-06-22
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190289000Karma® Fixation SystemSpinal Elements, Inc.2019-04-03OWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606167956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606167956008406061679568406061679560840606167956

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
610712213
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
00818720013381SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-05-29
00843575124395Juveno™ Femoral Hip SystemB-ONE ORTHO, CORP.LXH2026-05-29
07630345728883Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542726170Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753787Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753794Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788833Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788840Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788857Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788864Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788871Surgical Manual InstrumentMedacta International SALXH2026-05-29