FDA.reportPublic FDA data

OZARK Cervical Plate System

Primary DI
10888857411432
Brand
OZARK Cervical Plate System
Company
K2M, INC.
Model
8801-90084
Catalog number
8801-90084
Device description
Plate Bender
Published
2021-04-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857411432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885741143210888857411432

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 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

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