FDA.reportPublic FDA data

APEX 3D Total Ankle Replacement System

Primary DI
00889795150073
Brand
APEX 3D Total Ankle Replacement System
Company
Paragon 28, Inc.
Model
P11-700-TEMP
Catalog number
P11-700-TEMP
Device description
Diamond Tibia TAR X-ray Templates Packet
Published
2026-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795150073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795150073008897951500738897951500730889795150073

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795154804Grappler® Suture Anchor SystemP63-001-3510-SKP63-001-3510-SK2026-11-04
00889795154811Grappler® Suture Anchor SystemP63-001-4515-SKP63-001-4515-SK2026-11-04
00889795154828Grappler® Suture Anchor SystemP63-001-5515-SKP63-001-5515-SK2026-11-04
00889795150080APEX 3D Total Ankle Replacement SystemP11-710-TUF1P11-710-TUF12026-10-12
00889795150097APEX 3D Total Ankle Replacement SystemP11-710-TUF2P11-710-TUF22026-10-12
00889795150103APEX 3D Total Ankle Replacement SystemP11-710-TUF3P11-710-TUF32026-10-12
00889795150110APEX 3D Total Ankle Replacement SystemP11-710-TUF4P11-710-TUF42026-10-12
00889795150127APEX 3D Total Ankle Replacement SystemP11-710-TUF5P11-710-TUF52026-10-12
00889795150134APEX 3D Total Ankle Replacement SystemP11-710-TUF6P11-710-TUF62026-10-12
00889795150141APEX 3D Total Ankle Replacement SystemP11-754-CS12P11-754-CS122026-10-12
00889795150158APEX 3D Total Ankle Replacement SystemP11-754-CT12P11-754-CT122026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemP11-754-CS14P11-754-CS142026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemP11-754-CT14P11-754-CT142026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemP11-754-CS16P11-754-CS162026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemP11-754-CT16P11-754-CT162026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemP11-754-DS12P11-754-DS122026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemP11-754-DT12P11-754-DT122026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemP11-754-DS14P11-754-DS142026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemP11-754-DT14P11-754-DT142026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemP11-754-DS16P11-754-DS162026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713840G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713857G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713864G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713871G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
10603295555643INHANCEDEPUY ORTHOPAEDICS, INC.HWT2026-11-03
04260056885877InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885891InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885914InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885938InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885952InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885976InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885990InterSpace® Hip Mold Trial Head 42 mmOSARTIS GmbHHWT2026-10-29
04260056886010InterSpace® Hip Mold Trial Head 48 mmOSARTIS GmbHHWT2026-10-29
04260056886034InterSpace® Hip Mold Trial Head 52 mmOSARTIS GmbHHWT2026-10-29
04260056886058InterSpace® Hip Mold Trial Head 56 mmOSARTIS GmbHHWT2026-10-29
04260056886072InterSpace® Hip Mold Trial Head 60 mmOSARTIS GmbHHWT2026-10-29
04260056886096InterSpace® Knee Mold Trial Femoral Component XSOSARTIS GmbHHWT2026-10-29
04260056886119InterSpace® Knee Mold Trial Femoral Component SOSARTIS GmbHHWT2026-10-29
04260056886133InterSpace® Knee Mold Trial Femoral Component MOSARTIS GmbHHWT2026-10-29
04260056886157InterSpace® Knee Mold Trial Femoral Component LOSARTIS GmbHHWT2026-10-29
04260056886171InterSpace® Knee Mold Trial Femoral Component XLOSARTIS GmbHHWT2026-10-29
04260056886195InterSpace® Knee Mold Trial Tibial Component XSOSARTIS GmbHHWT2026-10-29
04260056886218InterSpace® Knee Mold Trial Tibial Component SOSARTIS GmbHHWT2026-10-29
04260056886232InterSpace® Knee Mold Trial Tibial Component MOSARTIS GmbHHWT2026-10-29
04260056886256InterSpace® Knee Mold Trial Tibial Component LOSARTIS GmbHHWT2026-10-29
04260056886270InterSpace® Knee Mold Trial Tibial Component XLOSARTIS GmbHHWT2026-10-29
04260056886287InterSpace® Knee Mold Trial Tibial StemOSARTIS GmbHHWT2026-10-29
04260056886416InterSpace® Knee Mold Trial Tibial InsertOSARTIS GmbHHWT2026-10-29
04260056886423InterSpace® Knee Mold Trial Tibial Stemmed InsertOSARTIS GmbHHWT2026-10-29
00889024702493OsseoFitZimmer, Inc.HWT2026-10-27