Response 5.5/6.0 Spine 01-1300-0032

GUDID 00841132178508

Response 5.5/6.0 Polyaxial Reduction Screw Caddy

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132178508
NIH Device Record Key111ab43a-889b-4bde-919b-0d645f832f01
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse 5.5/6.0 Spine
Version Model Number01-1300-0032
Catalog Number01-1300-0032
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
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
Emailbsmith@orthopediatric.com
Phone+1(574)268-6379
Emailbsmith@orthopediatric.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132178508 [Primary]
GS100841132178508 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT
FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132178508]

Moist Heat or Steam Sterilization


[00841132178508]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.