FDA.reportPublic FDA data

APEX 3D Total Ankle Replacement System

Primary DI
00889795061898
Brand
APEX 3D Total Ankle Replacement System
Company
PARAGON 28, INC.
Model
P10-901-RGA2
Catalog number
P10-901-RGA2
Device description
APEX 3D-PS Total Ankle Replacement System, Resection Gap Checker, ARC/Flat-Cut
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00889795061898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795061898008897950618988897950618980889795061898

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795153845Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-1P50-900-BGSL-12026-02-19
00889795153852Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-2P50-900-BGSL-22026-02-19
00889795153883Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-3P50-900-BGSL-32026-02-19
00889795153890Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-4P50-900-BGSL-42026-02-19
00889795153906Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-1P50-900-SBSL-12026-02-19
00889795153913Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-2P50-900-SBSL-22026-02-19
00889795153944Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-3P50-900-SBSL-32026-02-19
00889795153951Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-4P50-900-SBSL-42026-02-19
00889795153968Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-5P50-900-SBSL-52026-02-19
00889795153975Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-6P50-900-SBSL-62026-02-19
00889795153982Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-7P50-900-SBSL-72026-02-19
00889795153999Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-5P50-900-BGSL-52026-02-19
00889795154002Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-6P50-900-BGSL-62026-02-19
00889795154019Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-7P50-900-BGSL-72026-02-19
00889795154026APEX 3D Total Ankle Replacement SystemP10-844-FTPPP10-844-FTPP2026-02-19
00889795153661Precision MIS Bunion SystemP27-200-1000P27-200-10002026-02-06
00889795128737Baby Gorilla/Gorilla Plating SystemP99-151-P51L-SP99-151-P51L-S2026-01-29
00889795110879APEX 3D Total Ankle Replacement SystemP99-151-P105-1-SP99-151-P105-1-S2026-01-28
00889795118400APEX 3D Total Ankle Replacement SystemP99-152-P104-SP99-152-P104-S2026-01-28
00889795118417APEX 3D Total Ankle Replacement SystemP99-152-P105-SP99-152-P105-S2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118131782LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
00888118131799LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
07640187463460POYA Medial TemplateBonebridge AGHWT2026-05-22
00888118145321PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00888118145338PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00889024706347OSS RS ROT Hinged Knee Provisional 20MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706354OSS RS ROT Hinged Knee Provisional 22MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706361OSS RS ROT Hinged Knee Provisional 14MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706378OSS RS ROT Hinged Knee Provisional 12MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706385OSS RS ROT Hinged Knee Provisional 16MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706392OSS RS ROT Hinged Knee Provisional 18MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706514REDUCED Z1 STD NECK TRL SZ 10-12Zimmer, Inc.HWT2026-03-19
00889024706521REDUCED Z1 STD NECK TRL SZ 0-9Zimmer, Inc.HWT2026-03-19
04046826472061MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472078MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472085MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
10885862609588VantageExactech, Inc.HWT2026-03-19
10885862648037EquinoxeExactech, Inc.HWT2026-03-19
10885862648044EquinoxeExactech, Inc.HWT2026-03-19
10885862648051EquinoxeExactech, Inc.HWT2026-03-19
10885862648068EquinoxeExactech, Inc.HWT2026-03-19
10885862648075EquinoxeExactech, Inc.HWT2026-03-19
10885862648082EquinoxeExactech, Inc.HWT2026-03-19
10885862659712N/AExactech, Inc.HWT2026-03-19
10885862659729N/AExactech, Inc.HWT2026-03-19
10885862659736N/AExactech, Inc.HWT2026-03-19
10885862659750N/AExactech, Inc.HWT2026-03-19
10885862659767N/AExactech, Inc.HWT2026-03-19
10885862659774N/AExactech, Inc.HWT2026-03-19
10885862659781N/AExactech, Inc.HWT2026-03-19