FDA.reportPublic FDA data

PolyLock Midfoot

Primary DI
00840124521797
Brand
PolyLock Midfoot
Company
FUSION ORTHOPEDICS, LLC
Model
TN-CA-2003
Catalog number
TN-CA-2003
Device description
Calcaneus Wave Plate Left Guide Medium
Published
2025-10-02
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
false

Product Codes#

Code, Name table
CodeName
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211843000PolyLock Plating SystemFusion Orthopedics2022-03-04HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124521797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124521797008401245217978401245217970840124521797

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
080307067
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
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
00840124526044FibFixFN-TH-4713FN-TH-47132026-09-25
00840124526051FibFixFN-TH-4713-SFN-TH-4713-S2026-09-25
00840124526068FibFixFN-TH-5713FN-TH-57132026-09-25
00840124526075FibFixFN-TH-5713-SFN-TH-5713-S2026-09-25
00840124516779FibFixTN-FN-9000TN-FN-90002026-04-09
00840124517783FibFixTN-FN-9000-STN-FN-9000-S2026-04-09
00840124521773PolyLock MidfootTN-CA-2501TN-CA-25012025-10-02
00840124521780PolyLock MidfootTN-CA-2004TN-CA-20042025-10-02
00840124521803PolyLock MidfootTN-CA-2002TN-CA-20022025-10-02
00840124521810PolyLock MidfootTN-CA-2001TN-CA-20012025-10-02
00840124521827PolyLock MidfootTN-CA-2503TN-CA-25032025-10-02
00840124521834PolyLock MidfootTN-CA-2502TN-CA-25022025-10-02
00840124521841PolyLock MidfootTN-CA-2504TN-CA-25042025-10-02
00840124525467FibFixTN-FN-9000-ATN-FN-9000-A2026-04-09
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00840124519220IntraLockTN-LL-5861TN-LL-58612025-05-14
00840124519244LapiLockTN-LL-5075TN-LL-50752025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118155580UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155597UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155603UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155610UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155627UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155634UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155641UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155658UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155665UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155672UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155689UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155696UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155702UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155719UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155726UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155733UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155740UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155757UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155764UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00688346003918Fine TTOLaboratoires Bodycad IncPBF2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00885556925379CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
00885556925386CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
054005500102173D-CUT3D-SidePBF2026-04-28
054005501506163D-CUT3D-SidePBF2026-04-28
054005501506233D-CUT3D-SidePBF2026-04-28
054005501506303D-CUT3D-SidePBF2026-04-28