Panta 2 Arthrodesis Nail System PAN-1010-1438NS

GUDID 00885556829233

PANTA 5.0MM FULLY THREADED SIZE 38

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00885556829233
NIH Device Record Key8a8e15fd-39e6-4014-8a3e-bf046286854a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanta 2 Arthrodesis Nail System
Version Model NumberPAN-1010-1438NS
Catalog NumberPAN-1010-1438NS
Company DUNS045483575
Company NameSmith & Nephew, 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 Usetrue
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(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556829233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

[00885556829233]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-07
Device Publish Date2022-12-22

On-Brand Devices [Panta 2 Arthrodesis Nail System]

00885556828885COMPRESSION DEVICE
00885556828878TARGETING GUIDE
00885556828854TARGET GUIDE SUPPORT
00885556828847DRIVER SHAFT - 3.5MM HEX SCREWDRIVER
00885556828830TROCAR - 4.1MM DIAMETER
00885556828823TISSUE PROTECTOR REMOVAL TOOL
00885556828786CALCANEUS TISSUE PROTECTOR. 7MM DIAMETER
00885556828755DEPTH GAUGE
00885556828748COMPRESSION WHEEL
00885556828724HANDLE. NAIL FIXATION BOLT
00885556828717NAIL FIXATION BOLT
00885556828700THREADED AXIS
00885556828687EXTERNAL PROTECTION SLEEVE. DIAMETER 13.5MM
00885556828670CENTRAL PROTECTION SLEEVE. DIAMETER 9MM
00885556828663INTERNAL PROTECTION SLEEVE. DIAMETER 3.2MM
00885556829585END CAP
00885556828960SCREW CASE LID
00885556828953SCREW CASE
00885556828946PANTA 2 LID
00885556828939TARGETING GUIDE TRAY
00885556828922TARGETING & COMPRESSION DEVICE CASE
00885556828915NAIL & SCREW PREP CASE
00885556828908SCREW CADDY
00885556828892SCREW CADDY LID
00885556828731FIXATION BOLT LOCK SCREW
00885556828519T-HANDLE WITH AO QUICK CONNECT
00885556842362PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 85
00885556842355PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 50
00885556842348PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 65
00885556842331PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 60
00885556842324PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 45
00885556842317PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 100
00885556842300PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 55
00885556842294PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 110
00885556842287PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 80
00885556842270PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 70
00885556842263PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 105
00885556842256PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 95
00885556842249PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 90
00885556842232PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 75
00885556829578PANTA 5.0MM PARTIALLY THREADED SIZE 110
00885556829561PANTA 5.0MM PARTIALLY THREADED SIZE 105
00885556829554PANTA 5.0MM PARTIALLY THREADED SIZE 100
00885556829547PANTA 5.0MM PARTIALLY THREADED SIZE 95
00885556829530PANTA 5.0MM PARTIALLY THREADED SIZE 90
00885556829523PANTA 5.0MM PARTIALLY THREADED SIZE 85
00885556829516PANTA 5.0MM PARTIALLY THREADED SIZE 80
00885556829509PANTA 5.0MM PARTIALLY THREADED SIZE 75
00885556829493PANTA 5.0MM PARTIALLY THREADED SIZE 70
00885556829486PANTA 5.0MM PARTIALLY THREADED SIZE 65
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.