FDA.reportPublic FDA data

Atoll

Primary DI
10889981109493
Brand
Atoll
Company
Seaspine Orthopedics Corporation
Model
16-40-1601
Catalog number
16-40-1601
Device description
Connector Final Driver
Published
2016-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981109493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998110949310889981109493

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags#

DUNS number
079840876
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981172374Mariner Outrigger99-000899-00082019-07-26
10889981172466Mariner Outrigger99-001799-00172019-07-26
10889981172695Mariner Outrigger99-1010-1299-1010-122019-07-30
10889981172732Mariner Outrigger99-1012-1299-1012-122019-07-30
10889981172749Mariner Outrigger99-1012-1499-1012-142019-07-30
10889981172800Mariner Outrigger99-1015-1499-1015-142019-07-30
10889981184940Mariner Outrigger99-1023-1299-1023-122019-07-30
10889981125783Newport MIS64-856564-85652025-12-19
10889981125790Newport MIS64-857064-85702025-12-19
10889981125837NewPort64-957064-95702024-12-11
10889981125844NewPort64-958064-95802024-12-11
10889981130060NewPort64-555064-55502024-12-11
10889981130077NewPort64-657564-65752024-12-11
10889981130091NewPort64-853064-85302024-12-11
10889981134921NewPort64-472564-47252024-12-11
10889981134938NewPort64-476064-47602024-12-11
10889981134945NewPort64-475564-47552024-12-11
10889981135348NewPort64-553064-55302024-12-11
10889981135355NewPort64-553564-55352024-12-11
10889981135362NewPort64-554064-55402024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150083466Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150076468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00199150076475Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191623Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191746Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191753Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191944Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
03701089541022AMPLITUDEAMPLITUDE SASHXX2026-07-29
03700569670269Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569674649Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569679859Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680282Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680299Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
10887587078557NASynthes GmbHHXX2026-07-24
10887587078564NASynthes GmbHHXX2026-07-24
00888118154644LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21