FDA.reportPublic FDA data

Cannulated Screwdriver External sleeve Short

Primary DI
07290115935646
Brand
Cannulated Screwdriver External sleeve Short
Company
PREMIA SPINE LTD
Model
88266
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07290115935646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115935646072901159356467290115935646

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115935547Rod Holding Forceps832082024-10-01
07290115932812Left Alignment Gauge Superior Crossbars Long831062024-09-03
07290115932829Right Alignment Gauge Superior Crossbars Long831072024-09-03
07290115932850Left Alignment Gauge Superior Crossbars Medium861872024-09-03
07290115932867Right Alignment Gauge Superior Crossbars Medium861892024-09-03
07290014064973ProMIS™ Fixation System862412015-12-04
07290014064980ProMIS™ Fixation System862422015-12-04
07290014064997ProMIS™ Fixation System862432015-12-04
07290014080003ProMIS™ Fixation System862442015-12-04
07290014080010ProMIS™ Fixation System862452015-12-04
07290014080027ProMIS™ Fixation System862462015-12-04
07290014080034ProMIS™ Fixation System862472015-12-04
07290014080263ProMIS™ Fixation System864012016-02-04
07290014080270ProMIS™ Fixation System864022016-02-04
07290014080287ProMIS™ Fixation System864032016-02-04
07290014080294ProMIS™ Fixation System864042016-02-04
07290014080324ProMIS™ Fixation System867942016-03-29
07290115932508Tower Guide ST86261N2026-07-23
07290115935578PER Trial 60890602026-07-22
07290115935691PER Trial 50890972026-07-22

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