FDA.reportPublic FDA data

primaLOK SP

Primary DI
00813210022287
Brand
primaLOK SP
Company
Wenzel Spine, Inc.
Model
800-0228
Device description
Offset Provisional Locker
Published
2018-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K100354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100354000PRIMAL OK INTERSPINOUS FUSION SYSTEMOsteomed LP2010-08-17KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813210022287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813210022287008132100222878132100222870813210022287

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
855-936-9389info@wenzelspine.com

Regulatory Flags#

DUNS number
832543255
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813210020726VariLift-LXCIE2-A012-C012025-09-23
00813210020733VariLift-LXCIE2-A013-C012025-09-23
00813210020009VariLift-LCIE2-11-24-002015-12-17
00813210020016VariLift-LCIE2-13-24-002015-12-17
00813210020023VariLift-LCIE2-15-24-002015-12-17
00813210020030VariLift-CCIC1-7.5-12-BP2015-12-17
00813210020047VariLift-CCIC1-9.0-12-BP2015-12-17
00813210020054VariLift-CCIC1-7.5-12-002016-05-16
00813210020061VariLift-CCIC1-9.0-12-002016-05-16
00813210020078VariLift-LXCIE3-11-24-002016-02-18
00813210020085VariLift-LXCIE3-13-24-002016-02-18
00813210020092VariLift-LXCIE3-12-24-002016-02-18
00813210020108VariLift-LXCIE3-14-24-002016-02-18
00813210020115VariLift-LXCIE3-15-24-002016-02-18
00813210020122VariLift-LXCIE3-10-28-002016-02-18
00813210020139VariLift-LXCIE3-11-28-002016-02-18
00813210020146VariLift-LXCIE3-12-28-002016-02-18
00813210020153VariLift-LXCIE3-13-28-002016-02-18
00813210020160VariLift-LXCIE3-14-28-002016-02-18
00813210020177VariLift-LXCIE3-15-28-002016-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWP2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWP2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24