FDA.reportPublic FDA data

WasherCap™ Countersink Positioner 9mm

Primary DI
08437019739683
Brand
WasherCap™ Countersink Positioner 9mm
Company
ABANZA TECNOMED SL.
Model
21
Device description
Instrument that is inserted into the tunnel to perpendicularly position the “positioning guide” element in order to facilitate cortical shaping.
Published
2023-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KILPositioner, Socket

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KILPositioner, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28437019739687PackageGS11In Commercial Distribution
08437019739683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2843701973968728437019739687
08437019739683084370197396838437019739683

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(866) 550-7070customerservice@abanzamed.com

Regulatory Flags#

DUNS number
465714287
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437019739744QuadLock™ Fixation System 9mmNA2026-01-14
08437019739751QuadLock™ Fixation System 10mmNA2026-01-14
08437019739768QuadLock™ Fixation System 11mmNA2026-01-14
08437019739430WasherCap™ Countersink 11 mm212026-03-30
08437019739447WasherCap™ Inserter 11mm212026-03-30
08437019739454WasherCap™ Countersink Positioner 11mm212026-03-30
08437019739461Inserter Coupling Screw 11mm212026-03-30
28437019739748QuadLock™ Fixation System 9mmNA2026-01-14
28437019739755QuadLock™ Fixation System 10mmNA2026-01-14
28437019739762QuadLock™ Fixation System 11mmNA2026-01-14
08437019739867WasherCap™ Fixation System 11mm212025-03-10
28437019739861WasherCap™ Fixation System 11mm212025-03-10
08437019739898WasherCap Mini Fixation system 3.5mm452025-02-25
08437019739904WasherCap Mini Fixation system 4.5mm452025-02-25
28437019739892WasherCap Mini Fixation system 3.5mm452025-02-25
28437019739908WasherCap Mini Fixation system 4.5mm452025-02-25
08437019739485WasherCap™ Inserter 7mm & 8mm212023-06-01
08437019739508WasherCap™ Inserter 9mm & 10mm212023-06-01
08437019739669WasherCap™ Countersink Positioner 7mm212023-06-01
08437019739676WasherCap™ Countersink Positioner 8mm212023-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277133618Innomed, Inc.INNOMED, INC.KIL2026-04-21
08437019739454WasherCap™ Countersink Positioner 11mmABANZA TECNOMED SL.KIL2026-03-30
06974940306727endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
06974940306758endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
00840277133182Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133199Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133205Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133212Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133229Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133236Innomed, Inc.INNOMED, INC.KIL2026-02-06
06974940306680endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
06974940306697endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
00840277133021Innomed, Inc.INNOMED, INC.KIL2025-11-10
00840277132888Innomed, Inc.INNOMED, INC.KIL2025-10-14
00840277132765Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132772Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132789Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132796Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132802Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132833Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132734Innomed, Inc.INNOMED, INC.KIL2025-08-27
00840277132659Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132666Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132628Innomed, Inc.INNOMED, INC.KIL2025-08-04
00840277132611Innomed, Inc.INNOMED, INC.KIL2025-07-09
00840277132406Innomed, Inc.INNOMED, INC.KIL2025-06-25
00840277132390Innomed, Inc.INNOMED, INC.KIL2025-06-17
00840277132239Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132246Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132253Innomed, Inc.INNOMED, INC.KIL2025-06-04