FDA.reportPublic FDA data

PRECICE® Plating System

Primary DI
00887517016003
Brand
PRECICE® Plating System
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
PPT1-001
Catalog number
PPT1-001
Device description
PRECICE Plate Template Shaft, Right
Published
2019-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517016003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517016003008875170160038875170160030887517016003

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-435-5477csdepartment@nuvasive.com
866-456-2871info@globusmedical.com

Regulatory Flags#

DUNS number
837845234
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517952219PRECICE® STRYDE SystemSST-010-000SST-010-0002018-10-19
00887517952226PRECICE® STRYDE SystemSST-010-005SST-010-0052018-10-19
00887517952233PRECICE® STRYDE SystemSST-010-010SST-010-0102018-10-19
00887517952240PRECICE® STRYDE SystemSST-010-015SST-010-0152018-10-19
00887517952257PRECICE® STRYDE SystemSST-010-020SST-010-0202018-10-19
00887517952264PRECICE® STRYDE SystemSST-013-000SST-013-0002018-10-19
00887517952271PRECICE® STRYDE SystemSST-013-005SST-013-0052018-10-19
00887517952288PRECICE® STRYDE SystemSST-013-010SST-013-0102018-10-19
00887517952295PRECICE® STRYDE SystemSST-013-015SST-013-0152018-10-19
00887517952301PRECICE® STRYDE SystemSST-013-020SST-013-0202018-10-19
00887517001139PRECICE® Intramedullary Limb Lengthening SystemCPA2-000CPA2-0002017-10-10
00887517001146PRECICE® Intramedullary Limb Lengthening SystemCPA2-005CPA2-0052017-10-10
00887517001153PRECICE® Intramedullary Limb Lengthening SystemCPA2-010CPA2-0102017-10-10
00887517001160PRECICE® Intramedullary Limb Lengthening SystemCPA2-015CPA2-0152017-10-10
00887517001177PRECICE® Intramedullary Limb Lengthening SystemCPA2-020CPA2-0202017-10-10
00887517001184PRECICE® Intramedullary Limb Lengthening SystemCPA3-000CPA3-0002017-10-10
00887517001191PRECICE® Intramedullary Limb Lengthening SystemCPA3-005CPA3-0052017-10-10
00887517001207PRECICE® Intramedullary Limb Lengthening SystemCPA3-010CPA3-0102017-10-10
00887517001214PRECICE® Intramedullary Limb Lengthening SystemCPA3-015CPA3-0152017-10-10
00887517001221PRECICE® Intramedullary Limb Lengthening SystemCPA3-020CPA3-0202017-10-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806373887741BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887758BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887765BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
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09348215164591Longboard Trial Neck HOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
G791EFTEMPS080WishFIXRed Star Contract Manufacturing Inc.HWT2025-10-06
07613327524536INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524543INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524550INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327548716InstrumentHowmedica Osteonics Corp.HWT2024-02-22
07613327565850INSTRUMENTHowmedica Osteonics Corp.HWT2024-01-08
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09348215085001Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
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