FDA.report

EVEREST Spinal System

Primary DI
10888857562691
Brand
EVEREST Spinal System
Company
K2M, INC.
Model
PRO-1054
Catalog number
PRO-1054
Device description
Straight Hook Holder
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888857562691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088885756269110888857562691

GMDN Terms

TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags

DUNS number
146060863
Device count
1
DM exempt
false
Premarket exempt
true
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 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

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