Response 5.5/6.0 Spine 44-1300-0150

GUDID 00841132137406

RESPONSE 5.5/6.0 EXTRA UNIAXIAL AND POLYAXIAL SCREW

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132137406
NIH Device Record Keyec72a069-2905-4cf2-967b-5e701e3213d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse 5.5/6.0 Spine
Version Model Number44-1300-0150
Catalog Number44-1300-0150
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
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(574)268-6379
EmailRzorn@OrthoPediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132137406 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-29

On-Brand Devices [Response 5.5/6.0 Spine]

00841132137420RESPONSE 5.5/6.0 EXTRA LARGE-SIZE SCREW
00841132137413RESPONSE 5.5/6.0 EXTRA LP ROD REDUCTION TOWER
00841132137406RESPONSE 5.5/6.0 EXTRA UNIAXIAL AND POLYAXIAL SCREW
00841132137390RESPONSE 5.5/6.0 EXTRA JIMINY
00841132137383RESPONSE 5.5/6.0 ROD CUTTER
00841132137376RESPONSE 5.5/6.0 FIXED ANGLE SCREW
00841132137369RESPONSE 5.5/6.0 HOOK
00841132137352RESPONSE 5.5/6.0 REDUCTION SCREW
00841132137345RESPONSE 5.5/6.0 POLYAXIAL SCREW
00841132137338RESPONSE 5.5/6.0 UNIAXIAL SCREW
00841132137321RESPONSE 5.5/6.0 COUPLE DEROTATION
00841132137314RESPONSE 5.5/6.0 TORQUE
00841132137307RESPONSE 5.5/6.0 BENDER
00841132137291RESPONSE 5.5/6.0 ROD REDUCTION
00841132137284RESPONSE 5.5/6.0 PEDICLE PREP
00841132137277RESPONSE 5.5/6.0 IMPLANTS & INSTRUMENTS
008411321453955.5MM SOLID TAP, DOUBLE LEAD, POWER
008411321453884.5MM SOLID TAP, DOUBLE LEAD, POWER
008411321453713.5MM SOLID TAP, DOUBLE LEAD, POWER
00841132178508Response 5.5/6.0 Polyaxial Reduction Screw Caddy
00841132178485Response 5.5/6.0 Uniaxial Reduction Screw Caddy
00841132184677NM Case- Tray 3
00841132184660NM Case- Tray 2
00841132184622NM Case- Caddy 1

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