FDA.reportPublic FDA data

TiMAX®

Primary DI
00887868548314
Brand
TiMAX®
Company
Biomet Orthopedics, LLC
Model
8140-27-046
Catalog number
814027046
Published
2022-11-15
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
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083843000
K905048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083843000LOCKING ANATOMIC & COMPOSITE PLATING SYSTEMDePuy Orthopaedics, Inc.2009-03-20HRS
K905048000ACE 3.5MM CORTICAL BONE SCREWAce Medical Co.1991-01-30HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868548314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868548314008878685483148878685483140887868548314

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24
00888480584711PRO OSTEON 500R5RB0405RB0402015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613298657KOMET GUIDE PIN/SCREWGebr. Brasseler GmbH & Co. KGHWC2026-10-14
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550252BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-08
08057717550276BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-08
B650SCS370450StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370500StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370550StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370600StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370650StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370700StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370750StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370800StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370850StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370900StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830700StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830750StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830800StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830850StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830900StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830950StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX831000StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31