FDA.reportPublic FDA data

APEX 3D Total Ankle Replacement System

Primary DI
00889795061928
Brand
APEX 3D Total Ankle Replacement System
Company
PARAGON 28, INC.
Model
P10-901-RSP1
Catalog number
P10-901-RSP1
Device description
APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 1
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
HTRRASP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795061928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795061928008897950619288897950619280889795061928

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889981443351SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
10889981443368SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
00190776416690MillenniumAvalign Technologies, Inc.HTR2026-02-16
03662663109574Mergence-A Preparation InstrumentationHighridge Medical, LLCHTR2026-02-11
00190376538969Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
00190376538976Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
03662663083720ActivLHighridge Medical, LLCHTR2026-02-03
03662663083737ActivLHighridge Medical, LLCHTR2026-02-03
03662663083744ActivLHighridge Medical, LLCHTR2026-02-03
00889024705524Identity 40MM Inset Humeral ProtectorZimmer, Inc.HTR2026-01-16
00840180543955General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00840180545058General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00888480490289Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490296Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490302Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490319Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490326Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
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00888480490401Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
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