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Jeil Bone Fixation System

by Jeil Medical Corporation

510(k) K050669

Jeil Bone Fixation System is a Class II device made by Jeil Medical Corporation, cleared under FDA 510(k) K050669 on 26 May 2005, active as of 7 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 7 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 7 Oct 2026.

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050669 Date26 May 2005ClearedStatusActive

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  • Withdrawn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
JEY
Device class
Class II
Regulation
21 CFR Part 872.4760
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

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

Cited by

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

Devices cleared under K050669

39 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 K050669
UDI-DISize and differences
Bone Fixation Screw Kit 112-080 KIT
Jeil Medical Corporation
112-080 KIT08806390852135
Single use: no
On the market
Jeil Bone Fixation System 112-080 KIT
Jeil Medical Corporation
112-080 KIT08806390878029
Single use: no
On the market
Leforte System Bone Plate / GBR System Bone Plate 12-ME-001-01
Jeil Medical Corporation
12-ME-001-0108809265150343
Single use: yes
On the market
Leforte System Bone Plate / GBR System Bone Plate 12-ME-001-02
Jeil Medical Corporation
12-ME-001-0208809265150350
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-003
Jeil Medical Corporation
14-AT-00308809265155010
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-004
Jeil Medical Corporation
14-AT-00408809265155027
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-004
Jeil Medical Corporation
14-AT-00408806390805612
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-006
Jeil Medical Corporation
14-AT-00608809265155041
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-006
Jeil Medical Corporation
14-AT-00608806390805629
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-008
Jeil Medical Corporation
14-AT-00808806390805636
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-008
Jeil Medical Corporation
14-AT-00808809265155058
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-010
Jeil Medical Corporation
14-AT-01008806390805643
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-010
Jeil Medical Corporation
14-AT-01008809265155065
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-012
Jeil Medical Corporation
14-AT-01208809265155072
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 14-AT-012
Jeil Medical Corporation
14-AT-01208806390805650
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 16-AT-004
Jeil Medical Corporation
16-AT-00408809265155096
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 16-AT-006
Jeil Medical Corporation
16-AT-00608809265155119
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 16-AT-008
Jeil Medical Corporation
16-AT-00808809265155126
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 16-AT-010
Jeil Medical Corporation
16-AT-01008809265155133
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 20-AT-004
Jeil Medical Corporation
20-AT-00408809265155157
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 20-AT-006
Jeil Medical Corporation
20-AT-00608809265155171
Single use: yes
On the market
Leforte System Bone Screw / GBR System Bone Screw 20-AT-008
Jeil Medical Corporation
20-AT-00808809265155188
Single use: yes
On the market
Leforte System Bone Screw 16-MD-004
Jeil Medical Corporation
16-MD-00408809265151012
Single use: yes
On the market
Leforte System Bone Screw 16-MD-006
Jeil Medical Corporation
16-MD-00608809265151036
Single use: yes
On the market
Leforte System Bone Screw 16-MD-008
Jeil Medical Corporation
16-MD-00808809265151043
Single use: yes
On the market
Leforte System Bone Screw 16-MD-010
Jeil Medical Corporation
16-MD-01008809265151050
Single use: yes
On the market
Leforte System Bone Screw 20-MN-006
Jeil Medical Corporation
20-MN-00608809265152033
Single use: yes
On the market
Leforte System Bone Screw 20-MN-006
Jeil Medical Corporation
20-MN-00608806390805599
Single use: yes
On the market
Leforte System Bone Screw 20-MN-008
Jeil Medical Corporation
20-MN-00808809265152040
Single use: yes
On the market
Leforte System Bone Screw 20-MN-008
Jeil Medical Corporation
20-MN-00808806390805605
Single use: yes
On the market
Leforte System Bone Screw 20-MN-008
Jeil Medical Corporation
20-MN-00808806390805667
Single use: yes
On the market
Leforte System Bone Screw 20-MN-010
Jeil Medical Corporation
20-MN-01008809265152057
Single use: yes
On the market
Leforte System Bone Screw 20-MN-010
Jeil Medical Corporation
20-MN-01008806390805674
Single use: yes
On the market
Leforte System Bone Screw 20-MN-012
Jeil Medical Corporation
20-MN-01208806390805681
Single use: yes
On the market
Leforte System Bone Screw 20-MN-012
Jeil Medical Corporation
20-MN-01208809265152064
Single use: yes
On the market
Leforte System Bone Screw 20-MN-014
Jeil Medical Corporation
20-MN-01408806390805698
Single use: yes
On the market
Leforte System Bone Screw 20-MN-014
Jeil Medical Corporation
20-MN-01408809265152071
Single use: yes
On the market
Leforte System Bone Screw 20-MN-016
Jeil Medical Corporation
20-MN-01608809265152088
Single use: yes
On the market
Salvin Dental Specialties SALVIN-TI-MESH-50X37
SALVIN DENTAL SPECIALTIES, LLC
SALVIN-TI-MESH-50X37 / SALVIN-TI-MESH-50X3700841336108493
Single use: yes
On the market

Similar devices

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

Other devices from Jeil Medical Corporation

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