FDA.reportPublic FDA data

SureLOK Mini Posterior Cervical/Upper Thoracic System

Primary DI
00840019907774
Brand
SureLOK Mini Posterior Cervical/Upper Thoracic System
Company
PRECISION SPINE, INC.
Model
04-4040
Catalog number
04-4040
Device description
4.0mm x 40mm SureLOK™ PC Screw
Published
2019-04-11
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
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150851000Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.2015-06-04KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019907774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019907774008400199077748400199077740840019907774

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
00840019978484Reform Ti39-RM-553039-RM-55302026-11-05
00840019978491Reform Ti39-RM-553539-RM-55352026-11-05
00840019978507Reform Ti39-RM-554039-RM-55402026-11-05
00840019978514Reform Ti39-RM-554539-RM-55452026-11-05
00840019978521Reform Ti39-RM-555039-RM-55502026-11-05
00840019978538Reform Ti39-RM-555539-RM-55552026-11-05
00840019978545Reform Ti39-RM-556039-RM-55602026-11-05
00840019978552Reform Ti39-RM-652539-RM-65252026-11-05
00840019978569Reform Ti39-RM-653039-RM-65302026-11-05
00840019978576Reform Ti39-RM-653539-RM-65352026-11-05
00840019978583Reform Ti39-RM-654039-RM-65402026-11-05
00840019978590Reform Ti39-RM-654539-RM-65452026-11-05
00840019978606Reform Ti39-RM-655039-RM-65502026-11-05
00840019978613Reform Ti39-RM-655539-RM-65552026-11-05
00840019978620Reform Ti39-RM-656039-RM-65602026-11-05
00840019978637Reform Ti39-RM-753039-RM-75302026-11-05
00840019978644Reform Ti39-RM-753539-RM-75352026-11-05
00840019978651Reform Ti39-RM-754039-RM-75402026-11-05
00840019978668Reform Ti39-RM-754539-RM-75452026-11-05
00840019978675Reform Ti39-RM-755039-RM-75502026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840019978484Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978491Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978507Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978514Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978521Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978538Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978545Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978552Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978569Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978576Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978583Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978590Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978606Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978613Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978620Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978637Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978644Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978651Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978668Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978675Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978682Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978699Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978705Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978712Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978729Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978736Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978743Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978750Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978767Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978774Reform TiPRECISION SPINE, INC.KWP2026-11-05