FDA.reportPublic FDA data

Fine osteotomy HA 4.5 Cortical Bone Screw - L52mm

Primary DI
00688346002829
Brand
Fine osteotomy HA 4.5 Cortical Bone Screw - L52mm
Company
Laboratoires Bodycad Inc
Model
037-131-052
Device description
Button Head Locking HA 4.5 Cortical Self Tapping Bone Screw - L52mm
Published
2023-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231314000Fine Osteotomy™Bodycad Laboratories, Inc.2023-06-02PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00688346002829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00688346002829006883460028296883460028290688346002829

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., surgical steel).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
202981171
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00688346002485Fine osteotomy HA 4.5 Cortical Bone Screw - L30mm037-106-0302023-10-20
00688346002492Fine osteotomy HA 4.5 Cortical Bone Screw - L32mm037-106-0322023-10-20
00688346002508Fine osteotomy HA 4.5 Cortical Bone Screw - L34mm037-106-0342023-10-20
00688346002515Fine osteotomy HA 4.5 Cortical Bone Screw - L36mm037-106-0362023-10-20
00688346002522Fine osteotomy HA 4.5 Cortical Bone Screw - L38mm037-106-0382023-10-20
00688346002539Fine osteotomy HA 4.5 Cortical Bone Screw - L40mm037-106-0402023-10-20
00688346002546Fine osteotomy HA 4.5 Cortical Bone Screw - L42mm037-106-0422023-10-20
00688346002553Fine osteotomy HA 4.5 Cortical Bone Screw - L44mm037-106-0442023-10-20
00688346002560Fine osteotomy HA 4.5 Cortical Bone Screw - L46mm037-106-0462023-10-20
00688346002577Fine osteotomy HA 4.5 Cortical Bone Screw - L48mm037-106-0482023-10-20
00688346002584Fine osteotomy HA 4.5 Cortical Bone Screw - L50mm037-106-0502023-10-20
00688346002591Fine osteotomy HA 4.5 Cortical Bone Screw - L52mm037-106-0522023-10-20
00688346002607Fine osteotomy HA 4.5 Cortical Bone Screw - L54mm037-106-0542023-10-20
00688346002614Fine osteotomy HA 4.5 Cortical Bone Screw - L56mm037-106-0562023-10-20
00688346002621Fine osteotomy HA 4.5 Cortical Bone Screw - L58mm037-106-0582023-10-20
00688346002638Fine osteotomy HA 4.5 Cortical Bone Screw - L60mm037-106-0602023-10-20
00688346002645Fine osteotomy HA 4.5 Cortical Bone Screw - L62mm037-106-0622023-10-20
00688346002652Fine osteotomy HA 4.5 Cortical Bone Screw - L64mm037-106-0642023-10-20
00688346002669Fine osteotomy HA 4.5 Cortical Bone Screw - L66mm037-106-0662023-10-20
00688346002676Fine osteotomy HA 4.5 Cortical Bone Screw - L68mm037-106-0682023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
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