FDA.reportPublic FDA data

A.L.P.S.®

Primary DI
00887868532283
Brand
A.L.P.S.®
Company
Biomet Orthopedics, LLC
Model
8162-04-014
Catalog number
816204014
Published
2021-08-13
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
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HTNWASHER, BOLT NUT
HTYPIN, FIXATION, SMOOTH
HWCScrew, fixation, bone
JDWPIN, FIXATION, THREADED
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HTNWasher, Bolt NutOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDWPin, Fixation, ThreadedOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083843000LOCKING ANATOMIC & COMPOSITE PLATING SYSTEMDePuy Orthopaedics, Inc.2009-03-20HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868532283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868532283008878685322838878685322830887868532283

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
00880304737488Cartridge Thread Adapter1100301661100301662020-02-13
05019279925377Cobalt MV Bone Cement4024384024382015-11-28
00880304370456CEMENT NOZZLE4149914149912017-07-28
00880304370517OPTIVAC415441542017-07-28
00880304476783Cobalt MV with Gentamicin4024394024392015-11-28
00880304560789Cobalt Bone Cement4022824022822015-11-28
00880304560796Cobalt HV with Gentamicin4022834022832015-11-28
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569653873NANEWCLIP TECHNICSHWC2026-11-05
03700569658274NANEWCLIP TECHNICSHWC2026-11-05
03700569658281NANEWCLIP TECHNICSHWC2026-11-05
03700569667931NANEWCLIP TECHNICSHWC2026-11-05
03700569667948NANEWCLIP TECHNICSHWC2026-11-05
03700569667955NANEWCLIP TECHNICSHWC2026-11-05
03700569667962NANEWCLIP TECHNICSHWC2026-11-05
03700569667979NANEWCLIP TECHNICSHWC2026-11-05
03700569667986NANEWCLIP TECHNICSHWC2026-11-05
03700569667993NANEWCLIP TECHNICSHWC2026-11-05
03700569668006NANEWCLIP TECHNICSHWC2026-11-05
03700569668013NANEWCLIP TECHNICSHWC2026-11-05
03700569668020NANEWCLIP TECHNICSHWC2026-11-05
03700569668037NANEWCLIP TECHNICSHWC2026-11-05
03700569668044NANEWCLIP TECHNICSHWC2026-11-05
03700569668051NANEWCLIP TECHNICSHWC2026-11-05
03700569668068NANEWCLIP TECHNICSHWC2026-11-05
03700569668075NANEWCLIP TECHNICSHWC2026-11-05
03700569668082NANEWCLIP TECHNICSHWC2026-11-05
03700569668099NANEWCLIP TECHNICSHWC2026-11-05
03700569668105NANEWCLIP TECHNICSHWC2026-11-05
03700569668112NANEWCLIP TECHNICSHWC2026-11-05
03700569668129NANEWCLIP TECHNICSHWC2026-11-05
03700569668136NANEWCLIP TECHNICSHWC2026-11-05
03700569668143NANEWCLIP TECHNICSHWC2026-11-05
03700569668150NANEWCLIP TECHNICSHWC2026-11-05
03700569668167NANEWCLIP TECHNICSHWC2026-11-05
03700569668174NANEWCLIP TECHNICSHWC2026-11-05
03700569668181NANEWCLIP TECHNICSHWC2026-11-05
03700569668198NANEWCLIP TECHNICSHWC2026-11-05