FDA.reportPublic FDA data

Fine Osteotomy implants - Distal femur

Primary DI
00688346002164
Brand
Fine Osteotomy implants - Distal femur
Company
Laboratoires Bodycad Inc
Model
015-330-102
Catalog number
015-330-102
Device description
Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws
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
HSRUnit, Traction, Hip, Non-Powered, Non-Penetrating
HWCScrew, Fixation, Bone
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSRUnit, Traction, Hip, Non-Powered, Non-PenetratingOrthopedic1
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
00688346002164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00688346002164006883460021646883460021640688346002164

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
00688346000115Fine Osteotomy disposable instruments - Distal femur015-330-601015-330-6012020-05-20
00688346000139Fine Osteotomy disposable instruments - Proximal tibia015-410-601015-410-6012020-05-20
00688346000528Fine Osteotomy disposable instruments - Distal femur015-330-602015-330-6022020-05-20
00688346000535Fine Osteotomy disposable instruments - Distal femur015-330-603015-330-6032020-05-20
00688346000542Fine Osteotomy disposable instruments - Proximal tibia015-410-602015-410-6022020-05-20
00688346000559Fine Osteotomy disposable instruments - Proximal tibia015-410-603015-410-6032020-05-20
00688346003918Fine TTO014-340-0012026-08-03
00688346005356Fine Osteotomy System - Femoral plate015-330-0042026-08-03
00688346005387Fine Osteotomy System - Femoral plate015-330-0072026-08-03
00688346005523Fine Osteotomy System - Tibial plate015-410-0042026-08-03
00688346005554Fine Osteotomy System - Tibial plate015-410-0072026-08-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLEAPSynthes GmbHHWC2024-02-23
00810112592252TriLEAPSynthes GmbHHWC2024-02-23
00810112592429TriLEAPSynthes GmbHHWC2024-02-23
00810112592450TriLEAPSynthes GmbHHWC2024-02-23
00810112592467TriLEAPSynthes GmbHHWC2024-02-23
00810112592474TriLEAPSynthes GmbHHWC2024-02-23
00810112592634TriLEAPSynthes GmbHHWC2024-02-23
00810112592832TriLEAPSynthes GmbHHWC2024-02-23
00810112592849TriLEAPSynthes GmbHHWC2024-02-23
00810112592986TriLEAPSynthes GmbHHWC2024-02-22
00810112592993TriLEAPSynthes GmbHHWC2024-02-22
00810112593006TriLEAPSynthes GmbHHWC2024-02-22
00810112593013TriLEAPSynthes GmbHHWC2024-02-22
00810112593020TriLEAPSynthes GmbHHWC2024-02-22
00810112593037TriLEAPSynthes GmbHHWC2024-02-22
00810112593044TriLEAPSynthes GmbHHWC2024-02-22
00810112593051TriLEAPSynthes GmbHHWC2024-02-22
00810112593068TriLEAPSynthes GmbHHWC2024-02-22
00810112593075TriLEAPSynthes GmbHHWC2024-02-22
00810112593082TriLEAPSynthes GmbHHWC2024-02-22
00810112593099TriLEAPSynthes GmbHHWC2024-02-22
00810112593105TriLEAPSynthes GmbHHWC2024-02-22
00810112593112TriLEAPSynthes GmbHHWC2024-02-22
00810112593129TriLEAPSynthes GmbHHWC2024-02-22
00810112593136TriLEAPSynthes GmbHHWC2024-02-22
00810112593143TriLEAPSynthes GmbHHWC2024-02-22
00810112593150TriLEAPSynthes GmbHHWC2024-02-22
00810112593167TriLEAPSynthes GmbHHWC2024-02-22
00810112593174TriLEAPSynthes GmbHHWC2024-02-22
00810112593181TriLEAPSynthes GmbHHWC2024-02-22