FDA.reportPublic FDA data

Zimmer Cannulated Screw System

Primary DI
00846468073978
Brand
Zimmer Cannulated Screw System
Company
Pioneer Surgical Technology, Inc.
Model
00-1147-034-00
Catalog number
00-1147-034-00
Device description
CANNULATED COUNTERSINK, 8.2mm TRINKLE - To be used with 6.5/7.0/7.5mm Screws
Published
2020-09-25
Public version status
New
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
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468073978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468073978008464680739788464680739780846468073978

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com
+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
true
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
00810212930497SURGIPROSSurgipros, LLCHTZ2026-05-22
10603295553625ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553632ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553649ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553656ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
00190376538945Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376538952Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700885Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700892Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00840180544709General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544716General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544662General InstrumentsALPHATEC SPINE, INC.HTZ2025-12-31
10603295553663ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553670ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553687ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553694ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553700ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295554929ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
00196449033638Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033669Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033683Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033423Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033430Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033447Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033478Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033485Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033492Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033584Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033607Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033621Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02