FDA.reportPublic FDA data

RemeOs™ Screw LAG Solid

Primary DI
06438394015449
Brand
RemeOs™ Screw LAG Solid
Company
Bioretec Oy
Model
B-FSL-3534
Catalog number
B-FSL-3534
Device description
RemeOs™ Screw LAG Solid 3.5 mm x 34 mm
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QJDAbsorbable Metallic Bone Fixation Fastener

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJDAbsorbable Metallic Bone Fixation FastenerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220030000RemeOs™ Screw LAG SolidBioretec, Ltd.2023-03-29QJD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438394015449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438394015449064383940154496438394015449

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, bioabsorbableA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length34Millimeter
Width3.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
368715301
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438394002708Activa InstrumentB-IP-3201B-IP-32012026-03-23
06438394002678Activa InstrumentB-IP-1501B-IP-15012026-03-23
06438394002685Activa InstrumentB-IP-2001B-IP-20012026-03-23
06438394002692Activa InstrumentB-IP-2701B-IP-27012026-03-23
06438394020382Activa InstrumentB-IP-3201B-IP-32012026-03-23
06438394010956Activa InstrumentB-IP-1502B-IP-15022026-03-23
06438394000018ActivaPin™B-AP-1520B-AP-15202026-02-05
06438394000025ActivaPin™B-AP-1530B-AP-15302026-02-05
06438394000032ActivaPin™B-AP-1540B-AP-15402026-02-05
06438394000049ActivaPin™B-AP-1550B-AP-15502026-02-05
06438394000056ActivaPin™B-AP-1560B-AP-15602026-02-05
06438394000063ActivaPin™B-AP-1570B-AP-15702026-02-05
06438394000070ActivaPin™B-AP-2020B-AP-20202026-02-05
06438394000087ActivaPin™B-AP-2030B-AP-20302026-02-05
06438394000094ActivaPin™B-AP-2040B-AP-20402026-02-05
06438394000100ActivaPin™B-AP-2050B-AP-20502026-02-05
06438394000117ActivaPin™B-AP-2060B-AP-20602026-02-05
06438394000124ActivaPin™B-AP-2070B-AP-20702026-02-05
06438394000155ActivaPin™B-AP-2750B-AP-27502026-02-05
06438394000179ActivaPin™B-AP-2770B-AP-27702026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124521407MetalogixFUSION ORTHOPEDICS, LLCQJD2025-09-30
00840124521414MetalogixFUSION ORTHOPEDICS, LLCQJD2025-09-30
00840124521766MetalogixFUSION ORTHOPEDICS, LLCQJD2025-09-30
06438394015395RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015401RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015418RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015425RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015432RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015456RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015463RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015470RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12