FDA.reportPublic FDA data

EVEREST® Spinal System

Primary DI
10888857042292
Brand
EVEREST® Spinal System
Company
K2M, INC.
Model
2911-06535
Catalog number
2911-06535
Device description
Polyaxial Screw, Size Ø6.5x35 mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857042292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885704229210888857042292

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
Length35Millimeter
Outer Diameter6.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
146060863
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
10888857596986K2M General InstrumentsPRO-1002-03PRO-1002-032026-03-24
10888857596993K2M General InstrumentsPRO-1002-04PRO-1002-042026-03-24
10888857580022LITe® Pedicle Based RetractorPRO-1388-01PRO-1388-012026-03-04
10888857580039LITe® Pedicle Based RetractorPRO-1388-02PRO-1388-022026-03-04
10888857580046LITe® Pedicle Based RetractorPRO-1388-03PRO-1388-032026-03-04
10888857580053LITe® Pedicle Based RetractorPRO-1388-04PRO-1388-042026-03-04
10888857580060LITe® Pedicle Based RetractorPRO-1388-05PRO-1388-052026-03-04
10888857580077LITe® Pedicle Based RetractorPRO-1388-06PRO-1388-062026-03-04
10888857580084LITe® Pedicle Based RetractorPRO-1388-07PRO-1388-072026-03-04
10888857563384Q Interbody Instruments8020-900208020-900202026-03-03
10888857563391Q Interbody Instruments8020-900218020-900212026-03-03
10888857563407Q Interbody Instruments8020-900228020-900222026-03-03
10888857563414Q Interbody Instruments8020-900238020-900232026-03-03
10888857563421Q Interbody Instruments8020-900248020-900242026-03-03
10888857563650Q Interbody Instruments8020-900868020-900862026-03-03
10888857574700Q Interbody Instruments8020-90092-GS8020-90092-GS2026-03-03
10888857578715Q Interbody Instruments8020-100018020-100012026-03-03
10888857578722Q Interbody Instruments8020-100028020-100022026-03-03
10888857578739Q Interbody Instruments8020-100038020-100032026-03-03
10888857578876Q Interbody Instruments8020-900258020-900252026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000794675CD HORIZON ESSENCE™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-08-14
00763000788018CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-07-10
00763000787837CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-06-14
00763000788001CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-15
00763000787813CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-04
00763000872236CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-03
00840314178336Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178343Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178350Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178367Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178374Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178381Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178398Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178404Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178411Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178428Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178435Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178442Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178459Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178466Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178473Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178480Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178497Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178503Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178510Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178527Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178534Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178541Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178558Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178565Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18