FDA.reportPublic FDA data

Elemax® PLIF

Primary DI
00846468066482
Brand
Elemax® PLIF
Company
Pioneer Surgical Technology, Inc.
Model
32-EL-INSRTFORK, SM
Device description
Inserter Fork, Small
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWRDRIVER, PROSTHESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468066482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468066482008464680664828464680664820846468066482

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(906)226-9909labeling@resolvesurg.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840298701902CODA™ Anterior Cervical Plate System58-2022010102022-01-0102023-01-19
00840298701971CODA™ Anterior Cervical Plate System58-2022010242022-01-0242023-01-19
00840298702039CODA™ Anterior Cervical Plate System58-2022020282022-02-0282023-01-19
00840298702268CODA™ Anterior Cervical Plate System58-2022040802022-04-0802023-01-19
00840298700134CODA™ Anterior Cervical Plate System58-202221018S2022-21-018S2023-01-19
00840298700028CODA™ Anterior Cervical Plate System58-202220014S2022-20-014S2023-01-19
00840298700110CODA™ Anterior Cervical Plate System58-202221014S2022-21-014S2023-01-19
00840298700677CODA™ Anterior Cervical Plate System58-2022302002022-30-2002023-01-24
00840298701957CODA™ Anterior Cervical Plate System58-2022010202022-01-0202023-01-19
00840298702022CODA™ Anterior Cervical Plate System58-2022020262022-02-0262023-01-19
00840298702251CODA™ Anterior Cervical Plate System58-2022040762022-04-0762023-01-19
00840298700608CODA™ Anterior Cervical Plate System58-2022222002022-22-2002023-01-24
00840298700776CODA™ Anterior Cervical Plate System58-2022100072022-10-0072023-01-25
00840298700905CODA™ Anterior Cervical Plate System58-2022207172022-20-7172023-01-19
00840298701933CODA™ Anterior Cervical Plate System58-2022010162022-01-0162023-01-19
00840298701988CODA™ Anterior Cervical Plate System58-2022010262022-01-0262023-01-19
00840298702091CODA™ Anterior Cervical Plate System58-2022020402022-02-0402023-01-19
00840298702114CODA™ Anterior Cervical Plate System58-2022020442022-02-0442023-01-19
00840298702138CODA™ Anterior Cervical Plate System58-2022030452022-03-0452023-01-19
00840298702176CODA™ Anterior Cervical Plate System58-2022030572022-03-0572023-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867500754Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500761Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500778Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500839Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500877Arthrex®ARTHREX, INC.HWR2026-03-13
10705034579085N/AMedos International SàrlHWR2026-03-05
G079C5080000250MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2026-01-30
0088902470557940mm Head PusherZimmer, Inc.HWR2026-01-16
04026575315727MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHWR2026-01-06
00840180543535General InstrumentsALPHATEC SPINE, INC.HWR2025-12-31
04719886910766U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-11-13
04719886910902USTAR II Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-11-13
10705034643564TRIALTISMedos International SàrlHWR2025-11-13
07640332476307SCARLET AL-T INSTRUMENTATIONSpineArt SAHWR2025-11-11
07640332476314SCARLET AL-T INSTRUMENTATIONSpineArt SAHWR2025-11-11
00190376662213IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662237IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662244IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662251IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662268IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662275IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662282IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662299IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662305IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662312IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00889797111331Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HWR2025-08-26
G079AOL1380Advantage -LUMBAR InterbodyIntelivation, LLCHWR2025-08-07
00763000879594ENDOSKELETON® TCSMEDTRONIC SOFAMOR DANEK, INC.HWR2025-07-25
10705034589725TRIALTIS Spine SystemDEPUY SPINE, LLCHWR2025-07-17
04719886909593U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-07-14