FDA.report

PolyLock Ankle

Primary DI
00840124508248
Brand
PolyLock Ankle
Company
FUSION ORTHOPEDICS, LLC
Model
AK-LF-1009
Catalog number
AK-LF-1009
Device description
Lateral Fibula Plate Anatomical, Left 9 Hole
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840124508248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124508248008401245082488401245082480840124508248

GMDN Terms

TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Sterilization Methods

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 DIBrandModelCatalogPublished
00840124525474PolyLock MidfootMF-LK-2748MF-LK-27482026-03-10
00840124525481PolyLock MidfootMF-NL-2748MF-NL-27482026-03-10
00840124525450Depth GaugeTN-DG-8000TN-DG-80002026-03-06
00840124525375FuzeFix Max FTFX-FT-2532-SFX-FT-2532-S2026-02-17
00840124525382FuzeFix Max FTFX-FT-2534-SFX-FT-2534-S2026-02-17
00840124525399FuzeFix Max FTFX-FT-2536-SFX-FT-2536-S2026-02-17
00840124525405FuzeFix Max FTFX-FT-2538-SFX-FT-2538-S2026-02-17
00840124525412FuzeFix Max FTFX-FT-2542-SFX-FT-2542-S2026-02-17
00840124525429FuzeFix Max FTFX-FT-2544-SFX-FT-2544-S2026-02-17
00840124525436FuzeFix Max FTFX-FT-2546-SFX-FT-2546-S2026-02-17
00840124525443FuzeFix Max FTFX-FT-2548-SFX-FT-2548-S2026-02-17
00840124525320FuzeFix MiniTN-FX-6012TN-FX-60122026-02-03
00840124525337FuzeFix MiniTN-FX-6013TN-FX-60132026-02-03
00840124525344Metalogix RevolutionTN-TR-0095TN-TR-00952026-02-03
00840124525351Metalogix RevolutionTN-TR-0094TN-TR-00942026-02-03
00840124525368Metalogix RevolutionTN-TR-0090TN-TR-00902026-02-03
00840124525245FuzeFix MiniTN-FX-6011TN-FX-60112026-01-22
00840124525252Metalogix RevolutionTN-TR-0091TN-TR-00912026-01-22
00840124525269Metalogix RevolutionMX-RP-0120MX-RP-01202026-01-22
00840124525276Metalogix RevolutionMX-RP-0140MX-RP-01402026-01-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535152Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535176Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535190Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535213Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535237Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535251Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535275Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535299Arthrex®ARTHREX, INC.HRS2026-02-23