FDA.reportPublic FDA data

Fine Osteotomy disposable instruments - Distal femur

Primary DI
00688346000115
Brand
Fine Osteotomy disposable instruments - Distal femur
Company
Laboratoires Bodycad Inc
Model
015-330-601
Catalog number
015-330-601
Device description
Distal femur, disposable instruments (cutting guides, screws, drilling tower, pre-drill guide, validators)
Published
2020-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193614000FINE Osteotomy around the kneeBodycad Laboratories, Inc.2020-03-25HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00688346000115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00688346000115006883460001156883460001150688346000115

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
202981171
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00688346002577Fine osteotomy HA 4.5 Cortical Bone Screw - L48mm037-106-0482023-10-20

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