Panta 2 Arthrodesis Nail System PAN-1010-1500NS

GUDID 00885556829424

PANTA 5.0MM FULLY THREADED SIZE 100

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00885556829424
• NIH Device Record Key: 8cac9043-13ae-4851-82d7-02379a4e9aec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panta 2 Arthrodesis Nail System
• Version Model Number: PAN-1010-1500NS
• Catalog Number: PAN-1010-1500NS
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556829424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181639

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

[00885556829424]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2022-12-22

On-Brand Devices [Panta 2 Arthrodesis Nail System]

• 00885556828885: COMPRESSION DEVICE
• 00885556828878: TARGETING GUIDE
• 00885556828854: TARGET GUIDE SUPPORT
• 00885556828847: DRIVER SHAFT - 3.5MM HEX SCREWDRIVER
• 00885556828830: TROCAR - 4.1MM DIAMETER
• 00885556828823: TISSUE PROTECTOR REMOVAL TOOL
• 00885556828786: CALCANEUS TISSUE PROTECTOR. 7MM DIAMETER
• 00885556828755: DEPTH GAUGE
• 00885556828748: COMPRESSION WHEEL
• 00885556828724: HANDLE. NAIL FIXATION BOLT
• 00885556828717: NAIL FIXATION BOLT
• 00885556828700: THREADED AXIS
• 00885556828687: EXTERNAL PROTECTION SLEEVE. DIAMETER 13.5MM
• 00885556828670: CENTRAL PROTECTION SLEEVE. DIAMETER 9MM
• 00885556828663: INTERNAL PROTECTION SLEEVE. DIAMETER 3.2MM
• 00885556829585: END CAP
• 00885556828960: SCREW CASE LID
• 00885556828953: SCREW CASE
• 00885556828946: PANTA 2 LID
• 00885556828939: TARGETING GUIDE TRAY
• 00885556828922: TARGETING & COMPRESSION DEVICE CASE
• 00885556828915: NAIL & SCREW PREP CASE
• 00885556828908: SCREW CADDY
• 00885556828892: SCREW CADDY LID
• 00885556828731: FIXATION BOLT LOCK SCREW
• 00885556828519: T-HANDLE WITH AO QUICK CONNECT
• 00885556842362: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 85
• 00885556842355: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 50
• 00885556842348: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 65
• 00885556842331: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 60
• 00885556842324: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 45
• 00885556842317: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 100
• 00885556842300: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 55
• 00885556842294: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 110
• 00885556842287: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 80
• 00885556842270: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 70
• 00885556842263: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 105
• 00885556842256: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 95
• 00885556842249: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 90
• 00885556842232: PANTA 5.0MM PARTIALLY THREADED C-SCREW SIZE 75
• 00885556829578: PANTA 5.0MM PARTIALLY THREADED SIZE 110
• 00885556829561: PANTA 5.0MM PARTIALLY THREADED SIZE 105
• 00885556829554: PANTA 5.0MM PARTIALLY THREADED SIZE 100
• 00885556829547: PANTA 5.0MM PARTIALLY THREADED SIZE 95
• 00885556829530: PANTA 5.0MM PARTIALLY THREADED SIZE 90
• 00885556829523: PANTA 5.0MM PARTIALLY THREADED SIZE 85
• 00885556829516: PANTA 5.0MM PARTIALLY THREADED SIZE 80
• 00885556829509: PANTA 5.0MM PARTIALLY THREADED SIZE 75
• 00885556829493: PANTA 5.0MM PARTIALLY THREADED SIZE 70
• 00885556829486: PANTA 5.0MM PARTIALLY THREADED SIZE 65