FDA.reportPublic FDA data

NA

Primary DI
10885862553041
Brand
NA
Company
Exactech, Inc.
Model
01-007-05-0045
Catalog number
01-007-05-0045
Device description
4.5MM DRILL GUIDE
Published
2022-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141797000
K182346000
K896601000
K993082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141797000ALTEON 6.5MM BONE SCREWSExactech, Inc.2014-07-29LPH
K182346000TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.2018-11-26MBH
K896601000EXACTECH BONE SCREWExactech, Inc.1989-12-06HWC
K993082000EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENTExactech, Inc.1999-11-19LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862553041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586255304110885862553041

GMDN Terms#

Term, Definition table
TermDefinition
Surgical guillotineA manually-operated surgical instrument designed to cut body tissues and/or organs by using a sliding blade during a surgical intervention. It typically consists of a metal frame through which runs the sliding blade which is moved by the device operator with a handcrank mechanism. It is made of high-grade stainless steel and is available in various shapes and sizes depending on the tissue each is intended to cut. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862660527AcuMatch103-61-00103-61-002026-05-28
10885862660541AcuMatch103-61-07103-61-072026-05-28
10885862660558AcuMatch103-61-10103-61-102026-05-28
10885862660565AcuMatch103-61-97103-61-972026-05-28
10885862663207N/A101-14-00101-14-002026-05-28
10885862656117Newton02-521-90-200402-521-90-20042026-05-27
10885862656124Newton02-521-90-200502-521-90-20052026-05-27
10885862656131Newton02-521-90-200602-521-90-20062026-05-27
10885862656148Newton02-521-90-200702-521-90-20072026-05-27
10885862656155Newton02-521-90-200802-521-90-20082026-05-27
10885862656162Newton02-521-90-200902-521-90-20092026-05-27
10885862656179Newton02-521-90-201002-521-90-20102026-05-27
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26

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00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
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00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
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