FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867133921
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8970AL
Catalog number
AR-8970AL
Device description
ANKLE FUSION PLATE, ANTERIOR TT, LEFT
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE
HTNWASHER, BOLT NUT
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HTNWasher, Bolt NutOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867133921PrimaryGS10
M150AR8970AL0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867133921008888671339218888671339210888867133921

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
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
00888867461741Arthrex®AR-01-04-002AR-01-04-0022026-11-05
00888867461758Arthrex®AR-01-04-003AR-01-04-0032026-11-05
00888867461765Arthrex®AR-01-04-004AR-01-04-0042026-11-05
00888867473553Arthrex®AR-1288QAI-100AR-1288QAI-1002025-03-18
00888867473560Arthrex®AR-1288QAI-110AR-1288QAI-1102025-03-18
00888867473577Arthrex®AR-1288QAI-80AR-1288QAI-802025-03-18
00888867473584Arthrex®AR-1288QAI-90AR-1288QAI-902025-03-18
00888867473638Arthrex®AR-1288QTT-100AR-1288QTT-1002025-03-18
00888867473645Arthrex®AR-1288QTT-110AR-1288QTT-1102025-03-18
00888867473652Arthrex®AR-1288QTT-80AR-1288QTT-802025-03-18
00888867473669Arthrex®AR-1288QTT-90AR-1288QTT-902025-03-18
00888867034372Arthrex®AR-502-1LAR-502-1L2017-02-15
00888867034389Arthrex®AR-502-1RAR-502-1R2017-02-15
00888867034396Arthrex®AR-502-2LAR-502-2L2017-02-15
00888867034402Arthrex®AR-502-2RAR-502-2R2017-02-15
00888867034570Arthrex®AR-502-3LAR-502-3L2017-02-15
00888867034587Arthrex®AR-502-3RAR-502-3R2017-02-15
00888867034662Arthrex®AR-502-4LAR-502-4L2017-12-06
00888867034679Arthrex®AR-502-4RAR-502-4R2017-02-15
00888867035546Arthrex®AR-504-PSA8AR-504-PSA82017-02-15

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