FDA.reportPublic FDA data

Cannulated Screwdriver short

Primary DI
07290115935196
Brand
Cannulated Screwdriver short
Company
PREMIA SPINE LTD
Model
88263
Published
2024-09-03
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System
QWKProsthesis, Posterior Spinal Elements

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
QWKProsthesis, Posterior Spinal ElementsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150380000
K170061000
K231844000
P220002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150380000ProMIS Fixation SystemPremia Spine, Ltd.2015-07-17NKB
K170061000ProMIS™ Fixation SystemPremia Spine, Ltd.2017-02-02NKB
K231844000ProMIS™ Fixation SystemPremia Spine, Ltd.2023-07-07NKB
P220002000TOPS™ SystemPremia Spine, Ltd.2023-06-15QWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115935196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115935196072901159351967290115935196

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115932508Tower Guide ST86261N2026-07-23
07290115935578PER Trial 60890602026-07-22
07290115935691PER Trial 50890972026-07-22
07290115935837MIS Tower Guide86261N2026-06-01
07290115935349TOPS 2 - 21 S889442026-07-09
07290115935356TOPS 2 - 21 M889432026-07-09
07290115935363TOPS 2 - 21 L889422026-07-09
07290115935370TOPS 2 - 30 S889472026-07-09
07290115935387TOPS 2 - 30 M889462026-07-09
07290115935394TOPS 2 - 30 L889452026-07-09
07290115935400TOPS 2 - 38 S889502026-07-09
07290115935417TOPS 2 - 38 M889492026-07-09
07290115935424TOPS 2 - 38 L889482026-07-09
07290115935783TOPS 2 Inserter888932026-07-09
07290115932492Tower ST886062026-06-01
07290115932751Alignment Gauge Medium862022026-06-01
07290115932898Cannulated Screwdriver External sleeve865132026-06-01
07290115934076Tower ST Long Window889742026-06-01
07290115935622Cannulated Screwdriver Inner Shaft Short882642026-06-01
07290115935639Cannulated Screwdriver Handle Assy Short882652026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115932508Tower Guide STPREMIA SPINE LTDQWK2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDMNI2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDMNH2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDNKB2026-07-23
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCNKB2026-07-23
00840019935319Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019935364Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019934800Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934817Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934824Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934831Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934725Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934732Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934749Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934756Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934763Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934770Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934787Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934794Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934251Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934268Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934275Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934282Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934299Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934305Reform TIPRECISION SPINE, INC.NKB2019-09-10
00840019934312Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934329Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934336Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934343Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934350Reform TiPRECISION SPINE, INC.NKB2019-09-10