FDA.reportPublic FDA data

Fine Osteotomy system - Proximal tibia

Primary DI
00688346002256
Brand
Fine Osteotomy system - Proximal tibia
Company
Laboratoires Bodycad Inc
Model
015-410-001
Catalog number
015-410-001
Device description
Tibial plate, Cortical Compression Screws, cancellous Compression Screws and disposable instrumentation
Published
2021-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211646000FINE OsteotomyBodycad Laboratories, Inc.2021-07-28HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00688346002256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00688346002256006883460022566883460022560688346002256

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
202981171
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration 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

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Primary DI, Brand, Company table
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008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
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