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ARIX Rib System

by Jeil Medical Corporation

510(k) K221412

ARIX Rib System is a Class II device made by Jeil Medical Corporation, cleared under FDA 510(k) K221412 on 22 Nov 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221412 Date22 Nov 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K221412

124 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221412
UDI-DISize and differences
ARIX Rib System Bone Plate 24-CVRB-004
Jeil Medical Corporation
24-CVRB-00408806390880350
Single use: yes
On the market
ARIX Rib System Bone Plate 24-STRB-006
Jeil Medical Corporation
24-STRB-00608806390880398
Single use: yes
On the market
ARIX Rib System Bone Plate 24-STRB-010
Jeil Medical Corporation
24-STRB-01008806390880411
Single use: yes
On the market
ARIX Rib System Bone Plate S24-CVRB-006
Jeil Medical Corporation
S24-CVRB-00608806390880497
Single use: yes
On the market
ARIX Rib System Bone Plate S24-STRB-004
Jeil Medical Corporation
S24-STRB-00408806390880510
Single use: yes
On the market
ARIX Sternal System Bone Screw 24L-SA-S12-TA
Jeil Medical Corporation
24L-SA-S12-TA08806390880954
Single use: yes
On the market
ARIX Sternal System Bone Screw 24L-SA-S14-TA
Jeil Medical Corporation
24L-SA-S14-TA08806390880961
Single use: yes
On the market
ARIX Sternal System Bone Screw 24L-SA-S17-TA
Jeil Medical Corporation
24L-SA-S17-TA08800089434046
Single use: yes
On the market
ARIX Sternal System Bone Screw 24L-SA-S19-TA
Jeil Medical Corporation
24L-SA-S19-TA08800089434053
Single use: yes
On the market
ARIX Sternal System Bone Screw 27L-SA-S08-TA
Jeil Medical Corporation
27L-SA-S08-TA08806390881081
Single use: yes
On the market
ARIX Sternal System Bone Screw 27L-SA-S11-TA
Jeil Medical Corporation
27L-SA-S11-TA08800089434084
Single use: yes
On the market
ARIX Sternal System Bone Screw 27L-SA-S12-TA
Jeil Medical Corporation
27L-SA-S12-TA08806390881104
Single use: yes
On the market
ARIX Sternal System Bone Screw 27L-SA-S14-TA
Jeil Medical Corporation
27L-SA-S14-TA08806390881111
Single use: yes
On the market
ARIX Sternal System Bone Screw 27L-SA-S15-TA
Jeil Medical Corporation
27L-SA-S15-TA08800089434107
Single use: yes
On the market
ARIX Sternal System Bone Screw 27L-SA-S16-TA
Jeil Medical Corporation
27L-SA-S16-TA08806390881128
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S08-TA-2
Jeil Medical Corporation
S24L-SA-S08-TA-208806390881593
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S10-TA
Jeil Medical Corporation
S24L-SA-S10-TA08806390881616
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S11-TA
Jeil Medical Corporation
S24L-SA-S11-TA08800089433636
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S12-TA
Jeil Medical Corporation
S24L-SA-S12-TA08806390881647
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S13-TA
Jeil Medical Corporation
S24L-SA-S13-TA08800089433667
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S13-TA-2
Jeil Medical Corporation
S24L-SA-S13-TA-208800089433674
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S13-TA-4
Jeil Medical Corporation
S24L-SA-S13-TA-408800089433681
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S14-TA-2
Jeil Medical Corporation
S24L-SA-S14-TA-208806390881685
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S14-TA-4
Jeil Medical Corporation
S24L-SA-S14-TA-408806390881692
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S16-TA-2
Jeil Medical Corporation
S24L-SA-S16-TA-208806390881715
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S17-TA
Jeil Medical Corporation
S24L-SA-S17-TA08800089433728
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S17-TA-4
Jeil Medical Corporation
S24L-SA-S17-TA-408800089433742
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S19-TA-2
Jeil Medical Corporation
S24L-SA-S19-TA-208800089433766
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S19-TA-4
Jeil Medical Corporation
S24L-SA-S19-TA-408800089433773
Single use: yes
On the market
ARIX Sternal System Bone Screw S24L-SA-S20-TA-2
Jeil Medical Corporation
S24L-SA-S20-TA-208800089433797
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S08-TA
Jeil Medical Corporation
S27L-SA-S08-TA08806390881791
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S08-TA-4
Jeil Medical Corporation
S27L-SA-S08-TA-408806390881814
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S09-TA-2
Jeil Medical Corporation
S27L-SA-S09-TA-208800089433827
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S10-TA-2
Jeil Medical Corporation
S27L-SA-S10-TA-208806390881838
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S10-TA-4
Jeil Medical Corporation
S27L-SA-S10-TA-408806390881845
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S11-TA-2
Jeil Medical Corporation
S27L-SA-S11-TA-208800089433858
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S12-TA
Jeil Medical Corporation
S27L-SA-S12-TA08806390881852
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S12-TA-2
Jeil Medical Corporation
S27L-SA-S12-TA-208806390881869
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S12-TA-4
Jeil Medical Corporation
S27L-SA-S12-TA-408806390881876
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S13-TA
Jeil Medical Corporation
S27L-SA-S13-TA08800089433872
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S15-TA-2
Jeil Medical Corporation
S27L-SA-S15-TA-208800089433919
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S15-TA-4
Jeil Medical Corporation
S27L-SA-S15-TA-408800089433926
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S16-TA
Jeil Medical Corporation
S27L-SA-S16-TA08806390881913
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S18-TA-2
Jeil Medical Corporation
S27L-SA-S18-TA-208806390881951
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S19-TA-4
Jeil Medical Corporation
S27L-SA-S19-TA-408800089433988
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S20-TA
Jeil Medical Corporation
S27L-SA-S20-TA08800089427338
Single use: yes
On the market
ARIX Sternal System Bone Screw S27L-SA-S20-TA-2
Jeil Medical Corporation
S27L-SA-S20-TA-208800089433995
Single use: yes
On the market
Surgical Instrument 112-168
Jeil Medical Corporation
112-16808800089434138
Single use: no
On the market
Surgical Instrument 112-168-3
Jeil Medical Corporation
112-168-308800089434145
Single use: no
On the market
Surgical Instrument 112-168-7
Jeil Medical Corporation
112-168-708800089436880
Single use: no
On the market

Similar devices

Other devices filed under FDA product code HRS (Plate, Fixation, Bone).

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