FDA.reportPublic FDA data

P.L.U.S.®

Primary DI
03663136024738
Brand
P.L.U.S.®
Company
SPINEVISION
Model
U1-A125
Device description
CANNULATED TRIFINE FOR ILIO SACRAL FIXATION
Published
2015-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWKTREPHINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663136024738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663136024738036631360247383663136024738

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
390377518
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663136001869C3® ACPSC1-P1 02652015-10-15
03663136001876C3® ACPSC1-P1 0265N12015-10-15
03663136001883C3® ACPSC1-P1 02902015-10-15
03663136001913C3® ACPSC1-P1 0315N12015-10-15
03663136001944C3® ACPSC1-P1 03652015-10-15
03663136002095C3® ACPSC1-P2 0540N12015-10-15
03663136002170C3® ACPSC1-P3 06902015-10-15
03663136002262C3® ACPSC1-P4 08902015-10-15
03663136002309C3® ACPSC1-P4 10502015-10-15
03663136019482C3® ACPSC1-L1 03902015-10-15
03663136019574C3® ACPSC1-L3 05702015-10-15
03663136001821C3® ACPSC1-P1 02152015-10-15
03663136001838C3® ACPSC1-P1 0215N12015-10-15
03663136001845C3® ACPSC1-P1 02402015-10-15
03663136001852C3® ACPSC1-P1 0240N12015-10-15
03663136001890C3® ACPSC1-P1 0290N12015-10-15
03663136001920C3® ACPSC1-P1 03402015-10-15
03663136001937C3® ACPSC1-P1 0340N12015-10-15
03663136001951C3® ACPSC1-P1 0365N12015-10-15
03663136001968C3® ACPSC1-P1 03902015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
108101284636284.5mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636357.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636428.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636599.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
00190376706467InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706474InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706481InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706498InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706504InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706511InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706528InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706535InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706542InvictusALPHATEC SPINE, INC.HWK2026-04-09
03662663217477Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217484Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217491Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217507Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663134392C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHWK2025-12-03
03662663136327Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136334Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136341Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136358Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136365Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
06957277203112iTool®Apex (Guangzhou) Tools & Orthopedics Co.HWK2025-10-31
06957277203129iTool®Apex (Guangzhou) Tools & Orthopedics Co.HWK2025-10-31
06957277203136iTool®Apex (Guangzhou) Tools & Orthopedics Co.HWK2025-10-31
04262494460494N/ADoppkon GmbH & Co. KGHWK2025-09-10
04262494460500N/ADoppkon GmbH & Co. KGHWK2025-09-10
04262494460517N/ADoppkon GmbH & Co. KGHWK2025-09-10
04262494460524N/ADoppkon GmbH & Co. KGHWK2025-09-10