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Home›USA›Ascension Orthopedics, Inc.

Ascension Orthopedics, Inc.

USA · Austin
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 0Class III 1unclassified 1
plus 3 registration records and 36 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
10active device licences
Class III 10
24 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 36 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Canada10 confirmed, 0 excluded
Manufacturer names merged into this page: Ascension Orthopedics, Inc. · ASCENSION ORTHOPEDICS INC. · ASCENSION ORTHOPEDICS, INC.
Same-named companies — This database also contains companies with near-identical names: Ascension Orthopedic. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Austin

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12002
12003
22004
12005
32006
12007
12008
22009
62010
32011
22012
32013
22014
32015
12016
12017
12018
12023
12024

FDA listed device types

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis 1High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis 1Probe 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233674Freedom Wrist Arthroplasty System2024-05-30
USK233670Ascension Silicone MCP; Ascension Silicone PIP2023-12-14
USK182878Integra Salto Total Ankle System2018-12-18
BR80043770020EX FIX - Integra External Fixation SystemClass I
CA63082ASCENSION MODULAR RADIAL HEADClass III
CA73572ASCENSION CARBON MODULAR RADIAL HEADClass III
CA74416ASCENSION CMC SYSTEMClass III

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