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RemeOs™ Screw LAG Solid

by Bioretec Ltd.

De Novo DEN220030

RemeOs™ Screw LAG Solid is a Class II device made by Bioretec Ltd., granted FDA De Novo DEN220030 on 29 Mar 2023, active as of 26 Oct 2026.

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

Trust

Unverified

Source FDA De Novo, synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN220030 Date29 Mar 2023DecidedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA product code
QJD
FDA applicant
Bioretec, Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3041
Advisory committee
Orthopedic
FDA decision
DENG De Novo granted

Devices cleared under DEN220030

9 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 DEN220030
UDI-DISize and differences
RemeOs™ Screw LAG Solid B-FSL-3524
Bioretec Oy
B-FSL-3524 / B-FSL-352406438394015395
Width 3.5 mm; Length 24 mm
On the market
RemeOs™ Screw LAG Solid B-FSL-3526
Bioretec Oy
B-FSL-3526 / B-FSL-352606438394015401
Width 3.5 mm; Length 26 mm
On the market
RemeOs™ Screw LAG Solid B-FSL-3528
Bioretec Oy
B-FSL-3528 / B-FSL-352806438394015418
Width 3.5 mm; Length 28 mm
On the market
RemeOs™ Screw LAG Solid B-FSL-3530
Bioretec Oy
B-FSL-3530 / B-FSL-353006438394015425
Width 3.5 mm; Length 30 mm
On the market
RemeOs™ Screw LAG Solid B-FSL-3532
Bioretec Oy
B-FSL-3532 / B-FSL-353206438394015432
Width 3.5 mm; Length 32 mm
On the market
RemeOs™ Screw LAG Solid B-FSL-3534
Bioretec Oy
B-FSL-3534 / B-FSL-353406438394015449
Width 3.5 mm; Length 34 mm
On the market
RemeOs™ Screw LAG Solid B-FSL-3536
Bioretec Oy
B-FSL-3536 / B-FSL-353606438394015456
Width 3.5 mm; Length 36 mm
On the market
RemeOs™ Screw LAG Solid B-FSL-3538
Bioretec Oy
B-FSL-3538 / B-FSL-353806438394015463
Width 3.5 mm; Length 38 mm
On the market
RemeOs™ Screw LAG Solid B-FSL-3540
Bioretec Oy
B-FSL-3540 / B-FSL-354006438394015470
Width 3.5 mm; Length 40 mm
On the market

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