ALEUTIAN® Interbody Systems SP-4214-142

GUDID 10888857522664

Trial Size 13x16x15 mm, 30°

K2M, INC.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID10888857522664
NIH Device Record Keyd98210ee-0350-40ee-8902-48141f59a0ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameALEUTIAN® Interbody Systems
Version Model NumberSP-4214-142
Catalog NumberSP-4214-142
Company DUNS146060863
Company NameK2M, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com

Device Dimensions

Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter
Angle30 degree
Height15 Millimeter
Depth16 Millimeter
Width13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857522664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


[10888857522664]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [ALEUTIAN® Interbody Systems]

10888857430914Cervical Inserter, Size 16 mm
10888857430907Cervical Inserter, Size 14 mm
10888857429734Angled Lateral Inserter, 40°
10888857421080Angled Lateral Inserter, 25°
10888857415959Trial, Size 0
10888857399136Lateral Inserter Inner Shaft
10888857388659Horseshoe, Threaded Inserter,
10888857381506Cervical Inserter
10888857352711Cervical Inserter, Size 16 mm
10888857347311Inserter, Large Handle
10888857328747Inserter, Size 11x14 mm
10888857328679Inserter, Size 11x11 mm
10888857308084Parallel Rasp, Size 18x45x19 mm
10888857308077Parallel Rasp, Size 18x45x18 mm
10888857308060Parallel Rasp, Size 18x45x17 mm
10888857308053Parallel Rasp, Size 18x45x16 mm
10888857308046Parallel Rasp, Size 18x45x15 mm
10888857308039Parallel Rasp, Size 18x45x14 mm
10888857308022Parallel Rasp, Size 18x45x13 mm
10888857308015Parallel Rasp, Size 18x45x12 mm
10888857308008Parallel Rasp, Size 18x45x11 mm
10888857307995Parallel Rasp, Size 18x45x10 mm
10888857307988Parallel Rasp, Size 18x45x9 mm
10888857307971Parallel Rasp, Size 18x45x8 mm
10888857307964Parallel Rasp, Size 18x45x7 mm
10888857307957Parallel Rasp, Size 18x45x6 mm
10888857251144Lateral Inserter
10888857250970Lateral Inserter
10888857250321Convex Trial, Size 17x12x32 mm
10888857250314Convex Trial, Size 15x12x32 mm
10888857250307Convex Trial, Size 14x12x32 mm
10888857250291Convex Trial, Size 13x12x32 mm
10888857250284Convex Trial, Size 12x12x32 mm
10888857250277Convex Trial, Size 11x12x32 mm
10888857250260Convex Trial, Size 10x12x32 mm
10888857250253Convex Trial, Size 9x12x32 mm
10888857250246Convex Trial, Size 8x12x32 mm
10888857250239Convex Trial, Size 7x12x32 mm
10888857250222Convex Trial, Size 6x12x32 mm
10888857250215Convex Trial, Size 5x12x32 mm
10888857184589Lordotic Trial, Size 28x36x21 mm, 10°
10888857184572Lordotic Trial, Size 28x36x19 mm, 10°
10888857184565Lordotic Trial, Size 28x36x17 mm, 10°
10888857184558Lordotic Trial, Size 28x36x15 mm, 10°
10888857184541Lordotic Trial, Size 28x36x13 mm, 10°
10888857184534Lordotic Trial, Size 28x36x11 mm, 10°
10888857184527Lordotic Trial, Size 28x36x9 mm, 10°
10888857184510Lordotic Trial, Size 24x30x21 mm, 10°
10888857184503Lordotic Trial, Size 24x30x19 mm, 10°
10888857184497Lordotic Trial, Size 24x30x17 mm, 10°

Trademark Results [ALEUTIAN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALEUTIAN
ALEUTIAN
78725838 3266231 Live/Registered
K2M, INC.
2005-10-04
ALEUTIAN
ALEUTIAN
77702580 not registered Dead/Abandoned
Kohler Co.
2009-03-30
ALEUTIAN
ALEUTIAN
76350223 2717143 Dead/Cancelled
LOWE ALPINE UK LIMITED
2001-12-17
ALEUTIAN
ALEUTIAN
75870846 2556907 Live/Registered
GRAND BANKS YACHTS, LTD.
1999-12-10
ALEUTIAN
ALEUTIAN
74666721 not registered Dead/Abandoned
Lowe Alpine Systems, Inc.
1995-04-28
ALEUTIAN
ALEUTIAN
74639928 2002335 Dead/Cancelled
FISHKING PROCESSORS, INC.
1995-02-24
ALEUTIAN
ALEUTIAN
72421794 0992217 Dead/Expired
VITA FOOD PRODUCTS, INC.
1972-04-19
ALEUTIAN
ALEUTIAN
72309511 0872986 Dead/Expired
CROTON WATCH CO., INC.
1968-10-14
ALEUTIAN
ALEUTIAN
72109270 0739052 Dead/Expired
POPPER SHOE CORPORATION, THE
1960-11-29

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