FDA.reportPublic FDA data

Sure-Lok Extended Tab Pedicle Screw System

Primary DI
00840019922685
Brand
Sure-Lok Extended Tab Pedicle Screw System
Company
PRECISION SPINE, INC.
Model
48-1100
Catalog number
48-1100
Device description
Instrument & Implant Tray (Empty)
Published
2019-03-27
Public version status
Update
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

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
00840019922685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019922685008400199226858400199226850840019922685

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation implant/sterilization container setA collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00840019936798Sure-Lok Extended Tab Pedicle Screw System48-2000-CA48-2000-CA2019-09-03
00840019922661Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0004HXI-48-00042019-03-28
00840019922692Sure-Lok Extended Tab Pedicle Screw System48-200048-20002019-03-28
00840019922630Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0001HXI-48-00012019-03-27
00840019922647Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0002HXI-48-00022019-03-27
00840019922654Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0003HXI-48-00032019-03-27
00840019922678Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0005HXI-48-00052019-03-27
00840019925631PSS SystemHXI-SL-0001*HXI-SL-0001*2019-03-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHMNH2026-10-26
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHMNI2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHMNI2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHMNH2026-10-26
07290115935677XL AdaptorPREMIA SPINE LTDMNI2026-10-20
07290115935677XL AdaptorPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
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 LTDMNH2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNI2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNH2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNI2026-10-20
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 LTDMNH2026-10-18
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNI2026-10-18
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.MNH2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14