CHESAPEAKE Stabilization System SP-1566-08

GUDID 10888857297296

Distractor Size 21 mm

K2M, INC.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID10888857297296
NIH Device Record Key5f0eaded-ee43-4b07-9ac2-9aa3d1ec0e3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHESAPEAKE Stabilization System
Version Model NumberSP-1566-08
Catalog NumberSP-1566-08
Company DUNS146060863
Company NameK2M, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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

Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter
Height21 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857297296 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

[10888857297296]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-31
Device Publish Date2022-08-23

On-Brand Devices [CHESAPEAKE Stabilization System]

10888857404472Anti Torque Handle
10888857083264Implant Inserter, Adjustable Stops
10888857083011Ø3.5 mm Universal Drill, Screw Ø3.5x14 mm Screw
10888857083004Universal Awl
10888857082977Non-Tapered Universal Driver Size 10
10888857082960Universal Tapered Driver Size 10
10888857082953Universal Tap/Screw Ø3.5x14 mm Screw
10888857082823Inner Shaft, Threaded
10888857082793Single Barrel Drill/Screw Ø3.5x12 mm Screw
10888857082779Ø3.5 mm Drill, Screw Ø3.5x14 mm Screw
10888857082762Tap/Screw Ø3.5x14 mm Screw
10888857082625Non-Tapered Driver Size 10
10888857082618Tapered Driver Size 10
10888857082601Implant Pusher
10888857082595Awl
10888857082588Ø3.5 mm Drill, Screw
108888570825713-Screw Drill Guide Inserter Size 10 mm
108888570825643-Screw Drill Guide Inserter Size 9 mm
108888570825573-Screw Drill Guide Inserter Size 8 mm
108888570825403-Screw Drill Guide Inserter Size 7 mm
108888570825333-Screw Drill Guide Inserter Size 6 mm
108888570825263-Screw Drill Guide Inserter Size 5 mm
10888857082397Torque Limiting Handle Size 12 in-lbs (1.4 N-m)
10888857182752Universal Tapered Driver Size 20
10888857157712Drill Guide, Inserter Clip
10888857026582Expandable Drill Guide Size 17 mm
10888857026551Expandable Drill Guide Size 11 mm
10888857025745Zero Countersink Modular Tip Allograft
10888857025721Zero Countersink Modular Tip Chesapeake
10888857025714Universal Tap Size Ø5.25x20 mm
10888857025684Universal Drill Size Ø5.5x20 mm
10888857025646Awl Size 25 mm
10888857025639Spring Loaded Awl Size 20 mm
10888857025622Non-Tapered Driver Size 20
10888857025615Torque Handle Size 20 in-lbs (2.3 N-m)
10888857025585Tap Size 20 mm
10888857025554Tapered Driver Size 20
10888857025547Drill Size Ø5.5x20 mm
10888857025530Awl Size 20 mm
10888857025516Universal Awl Size 25 mm
10888857025509Universal Awl Size 20 mm
10888857025493Universal Tapered Driver Size 20
10888857025462Modular Tip Assembly
10888857025455Inner Shaft Assembly
10888857383494Universal Driver Size 20
10888857297296Distractor Size 21 mm
10888857297289Distractor Size 19 mm
10888857297272Distractor Size 17 mm
10888857297265Distractor Size 15 mm
10888857297258Distractor Size 13 mm
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