Precice Ankle Salvage System

GUDID 00195377066305

Precice Ankle Salvage Instrument Set

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00195377066305
NIH Device Record Key2b54db5d-412e-499e-b3a1-800057d99ff5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecice Ankle Salvage System
Version Model NumberAST1-000
Company DUNS837845234
Company NameNUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com
Phone866-456-2871
Emailinfo@globusmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100195377066305 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

[00195377066305]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-05-28
Device Publish Date2023-01-26

Devices Manufactured by NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

00195377024282 - Precice Instrument2025-05-28 Osteotomy Reference Guide
00195377066206 - Precice Instrument2025-05-28 Steinmann Pin, 3.2mm x 125mm
00195377066305 - Precice Ankle Salvage System2025-05-28Precice Ankle Salvage Instrument Set
00195377066305 - Precice Ankle Salvage System2025-05-28 Precice Ankle Salvage Instrument Set
00195377066701 - Precice Instrument2025-05-28 3.2mm x 330mm Steinmann Pin, Threaded Trocar Tip
00195377066718 - Precice Instrument2025-05-28 3.2mm x 330mm Steinmann Pin, Trocar Tip
00812258028602 - Precice Instrument2025-05-28 Screw Depth Gauge, 20-70mm
00887517001238 - Precice Instrument2025-05-28 Osteotomy Guide, Large
00887517001252 - Precice Instrument2025-05-28 Osteotomy Guide, Small
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