FDA.reportPublic FDA data

Atoll

Primary DI
10889981109295
Brand
Atoll
Company
Seaspine Orthopedics Corporation
Model
16-40-0801
Catalog number
16-40-0801
Device description
Hook Impactor
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
HWDSTARTER, BONE SCREW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWDStarter, Bone ScrewOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981109295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998110929510889981109295

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. 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
10889981080877Malibu91-214791-21472016-05-02
10889981125820Newport Complex MIS64-956564-95652026-03-03
10889981125851Newport Complex MIS64-959064-95902026-03-03
10889981130084Newport Complex MIS64-750564-75052026-03-03
10889981135331Newport Complex MIS64-552564-55252026-03-03
10889981135386Newport Complex MIS64-555564-55552026-03-03
10889981135393Newport Complex MIS64-556064-55602026-03-03
10889981135522Newport Complex MIS64-655064-65502026-03-03
10889981135553Newport Complex MIS64-656564-65652026-03-03
10889981135584Newport Complex MIS64-658564-65852026-03-03
10889981135591Newport Complex MIS64-659064-65902026-03-03
10889981135867Newport Complex MIS64-754564-75452026-03-03
10889981135997Newport Complex MIS64-851064-85102026-03-03
10889981136017Newport Complex MIS64-858564-85852026-03-03
10889981136079Newport Complex MIS64-957564-95752026-03-03
10889981136086Newport Complex MIS64-958564-95852026-03-03
10889981145668NewPort™65-474565-47452026-03-03
10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731134752Hintermann Series VILEX LLCHWD2025-09-17
00840019968867Dakota ALIF Plate SystemPRECISION SPINE, INC.HWD2025-03-13
00840180529270General InstrumentsALPHATEC SPINE, INC.HWD2024-08-01
B07315K0140200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
B07315K0160200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
00887868570940Distal Screw SheathBiomet Orthopedics, LLCHWD2023-08-15
00887868570049Distal ScrewBiomet Orthopedics, LLCHWD2023-06-13
00887868570124Lag Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570148Affixus®Biomet Orthopedics, LLCHWD2023-06-13
00887868570155Anti-Rotation Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570162Anti-Rotation Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570179Anti-Rotation Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570186Lag Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570193Lag Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570230Lag Screw TapBiomet Orthopedics, LLCHWD2023-06-13
00887868570247Distal Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00844856069756ArsenalALPHATEC SPINE, INC.HWD2023-05-13
00190376477954AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477961AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477978AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477985AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00885556864869Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864876Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864883Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864890Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864906Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
04026575182572LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-27
04026575046768Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-20
04026575395521SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-16
04026575347698LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-15