FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867275553
Brand
Arthrex®
Company
ARTHREX, INC.
Model
SP-643-42
Catalog number
SP-643-42
Device description
ACF, Distal Femoral Alignment Guide
Published
2018-05-30
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867275553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867275553008888672755538888672755530888867275553

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill guiding pinA sterile metal shaft (pin) designed to fit into the hollow centre of a cannulated surgical drill bit to provide a guide for drilling during a surgical procedure. The pin is bored into hard tissue (e.g., bone), typically by means of a surgical power tool handpiece, and the cannulated drill bit is subsequently fed over it during the drilling procedure. This is a single-use device.

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
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
00888867620964Arthrex®AR-3210-0067AR-3210-00672026-10-12
00888867620971Arthrex®AR-3210-0067-PKAR-3210-0067-PK2026-10-12
00888867620988Arthrex®AR-3210-0068AR-3210-00682026-10-12
00888867620995Arthrex®AR-3210-0068-PKAR-3210-0068-PK2026-10-12
00888867520745Arthrex®AR-1360FT-KFTAR-1360FT-KFT2026-01-21
00888867429857Arthrex®AR-2600FSB-1AR-2600FSB-12023-05-24
00888867429864Arthrex®AR-2600FSB-2AR-2600FSB-22023-05-24
00888867429871Arthrex®AR-2600FSB-3AR-2600FSB-32023-05-24
00888867429888Arthrex®AR-2600FSB-4AR-2600FSB-42023-05-24
00888867354067Arthrex®AR-1360FT-BCAR-1360FT-BC2020-12-15
00888867101951Arthrex®AR-3600DCAR-3600DC2018-12-21
00888867096066Arthrex®AR-1677BC-CPAR-1677BC-CP2017-02-15
00888867084384Arthrex®ABS-3005ABS-30052017-02-15
00888867084407Arthrex®ABS-3008ABS-30082017-02-15
00888867084421Arthrex®ABS-3016ABS-30162017-02-15
00888867084148Arthrex®ABS-2001-01ABS-2001-012017-02-15
00888867084155Arthrex®ABS-2001-02ABS-2001-022017-02-15
00888867084162Arthrex®ABS-2001-05ABS-2001-052017-02-15
00888867084179Arthrex®ABS-2001-10ABS-2001-102017-02-15
00888867084186Arthrex®ABS-2002-01ABS-2002-012017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27