FDA.reportPublic FDA data

MESA® Small Stature Spinal System

Primary DI
10888857054714
Brand
MESA® Small Stature Spinal System
Company
VB Spine LLC
Model
3011-64540
Catalog number
3011-64540
Device description
Contoured Rod Size Ø4.5x40 mm, CoCr
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131784000RANGE SPINAL SYSTEMK2m, Inc.2013-08-30OSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857054714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885705471410888857054714

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(703)777-3155sgilbert@k2m.com
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
119508156
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888857615694CHESAPEAKE® Stabilization SystemPRO-1436-02PRO-1436-022026-09-23
10888857615724OZARK Cervical Plate SystemPRO-1445PRO-14452026-09-22
10888857613805Xia® 3PRO-1438PRO-14382026-06-11
10888857613812K2M General InstrumentsPRO-1439PRO-14392026-06-12
10888857599710YUKON OCT Spinal SystemPRO-1435PRO-14352026-08-25
10888857598256Xia® 3 System - Serrato®482614535V482614535V2026-07-24
10888857598263Xia® 3 System - Serrato®482614540V482614540V2026-07-24
10888857598270Xia® 3 System - Serrato®482614545V482614545V2026-07-24
10888857598287Xia® 3 System - Serrato®482615020V482615020V2026-07-24
10888857598294Xia® 3 System - Serrato®482615025V482615025V2026-07-24
10888857598300Xia® 3 System - Serrato®482615030V482615030V2026-07-24
10888857598317Xia® 3 System - Serrato®482615035V482615035V2026-07-24
10888857598324Xia® 3 System - Serrato®482615040V482615040V2026-07-24
10888857598331Xia® 3 System - Serrato®482615045V482615045V2026-07-24
10888857598348Xia® 3 System - Serrato®482615050V482615050V2026-07-24
10888857598355Xia® 3 System - Serrato®482615525V482615525V2026-07-24
10888857598362Xia® 3 System - Serrato®482615530V482615530V2026-07-24
10888857598379Xia® 3 System - Serrato®482615535V482615535V2026-07-24
10888857598386Xia® 3 System - Serrato®482615540V482615540V2026-07-24
10888857598393Xia® 3 System - Serrato®482615545V482615545V2026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157120962ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120979ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120986ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120993ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121006ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121013ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121020ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121037ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121044ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121051ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121068ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121075ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121082ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121099ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121105ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121112ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121129ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121136ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121143ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121150ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121167ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121174ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121181ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121198ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121204ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121211ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121228ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121235ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121242ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121259ZAVATION SCREWZavation LLCNKB2026-10-15