FDA.reportPublic FDA data

Sure-Lok Extended Tab Pedicle Screw System

Primary DI
00840019909372
Brand
Sure-Lok Extended Tab Pedicle Screw System
Company
PRECISION SPINE, INC.
Model
48-CU-55090
Catalog number
48-CU-55090
Device description
90mm curved rod
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141397000SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEMPrecision Spine, Inc.2014-06-26MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019909372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019909372008400199093728400199093720840019909372

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019978156Reform Ti39-TM-454539-TM-45452026-10-19
00840019978163Reform Ti39-TM-552039-TM-55202026-10-19
00840019978170Reform Ti39-TM-552539-TM-55252026-10-19
00840019978187Reform Ti39-TM-553039-TM-55302026-10-19
00840019978194Reform Ti39-TM-553539-TM-55352026-10-19
00840019978200Reform Ti39-TM-554039-TM-55402026-10-19
00840019978217Reform Ti39-TM-554539-TM-55452026-10-19
00840019978224Reform Ti39-TM-555039-TM-55502026-10-19
00840019978231Reform Ti39-TM-555539-TM-55552026-10-19
00840019978248Reform Ti39-TM-556039-TM-55602026-10-19
00840019978255Reform Ti39-TM-652539-TM-65252026-10-19
00840019978262Reform Ti39-TM-653039-TM-65302026-10-19
00840019978279Reform Ti39-TM-653539-TM-65352026-10-19
00840019978286Reform Ti39-TM-654039-TM-65402026-10-19
00840019978293Reform Ti39-TM-654539-TM-65452026-10-19
00840019978309Reform Ti39-TM-655039-TM-65502026-10-19
00840019978316Reform Ti39-TM-655539-TM-65552026-10-19
00840019978323Reform Ti39-TM-656039-TM-65602026-10-19
00840019978330Reform Ti39-TM-753039-TM-75302026-10-19
00840019978347Reform Ti39-TM-753539-TM-75352026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935677XL AdaptorPREMIA SPINE LTDMNI2026-10-20
07290115935677XL AdaptorPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNI2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNH2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNI2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNH2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNI2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNH2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNI2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNH2026-10-20
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNI2026-10-18
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNH2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNH2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNI2026-10-18
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14