FDA.reportPublic FDA data

PULSE

Primary DI
10705034389370
Brand
PULSE
Company
Medos International Sàrl
Model
310101630S
Catalog number
310101630S
Device description
PULSE LUMBAR SCREW SYSTEM POLYAXIAL SCREW 6 x 30mm
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113396000DEPUY PULSE THORACOLUMBAR SCREW SYSTEMMedos International SARL2012-02-08NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034389370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503438937010705034389370

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647807TRIALTIS5161-00-514551610051452026-06-03
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22
10886705030293NA2426542426542018-02-22
10705034606897TRIALTIS5560886545S5560886545S2026-05-29
10705034608679TRIALTIS5560520004S5560520004S2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
08800043949180N/ATDM Co., Ltd.KWQ2026-06-05
08800043965029N/ATDM Co., Ltd.KWQ2026-06-05
08800043965036N/ATDM Co., Ltd.KWQ2026-06-05
08800043965043N/ATDM Co., Ltd.KWQ2026-06-05
08800043965050N/ATDM Co., Ltd.KWQ2026-06-05
08800043965067N/ATDM Co., Ltd.KWQ2026-06-05
08800043965074N/ATDM Co., Ltd.KWQ2026-06-05
08800043965081N/ATDM Co., Ltd.KWQ2026-06-05
08800043965098N/ATDM Co., Ltd.KWQ2026-06-05
08800043965104N/ATDM Co., Ltd.KWQ2026-06-05
08800043965111N/ATDM Co., Ltd.KWQ2026-06-05
08800043965128N/ATDM Co., Ltd.KWQ2026-06-05
08800043965135N/ATDM Co., Ltd.KWQ2026-06-05
08800043965142N/ATDM Co., Ltd.KWQ2026-06-05
08800043965159N/ATDM Co., Ltd.KWQ2026-06-05
08800043965166N/ATDM Co., Ltd.KWQ2026-06-05
08800043965173N/ATDM Co., Ltd.KWQ2026-06-05
08800043965180N/ATDM Co., Ltd.KWQ2026-06-05
08800043965197N/ATDM Co., Ltd.KWQ2026-06-05
08800043965203N/ATDM Co., Ltd.KWQ2026-06-05
08800043965210N/ATDM Co., Ltd.KWQ2026-06-05
08800043965227N/ATDM Co., Ltd.KWQ2026-06-05
08800043965234N/ATDM Co., Ltd.KWQ2026-06-05
08800043965241N/ATDM Co., Ltd.KWQ2026-06-05
08800043965258N/ATDM Co., Ltd.KWQ2026-06-05
08800043965265N/ATDM Co., Ltd.KWQ2026-06-05
08800043965272N/ATDM Co., Ltd.KWQ2026-06-05
08800043965289N/ATDM Co., Ltd.KWQ2026-06-05