FDA.reportPublic FDA data

FiberLocker Implant

Primary DI
07649988202230
Brand
FiberLocker Implant
Company
ZuriMED Technologies AG
Model
SP019N1A
Device description
ZuriMED Technologies AG - FiberLocker Implant (SpeedPatch PET)
Published
2025-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241219000
K253867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241219000FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)ZuriMED Technologies AG2024-12-11OWX
K253867000FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG2026-01-02OWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649988202230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649988202230076499882022307649988202230

GMDN Terms#

Term, Definition table
TermDefinition
Surgical support tape, non-bioabsorbableA band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height30Millimeter
Width25Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480096456
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07649988202247FiberLocker InstrumentFL516SNA2025-02-10
07649988202209FiberLocker PowerUnit - Transfer ShieldPU7050A42026-02-02
07649988202278FiberLocker PowerUnit - HandpiecePU7050A12026-02-02
07649988202285FiberLocker PowerUnit - Motor PackPU7050A22026-02-02
07649988202292FiberLocker PowerUnit - Charging StationPU7050A32026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810198920130TekBrace SoloTheraMicro, LLCOWX2026-04-17
00817337000418Integrity ImplantAnika Therapeutics, Inc.OWX2026-01-05
05060267134516FORCEWEB 5 mm x 500 mmXIROS LTDOWX2025-11-19
00817337000425Integrity ImplantAnika Therapeutics, Inc.OWX2025-09-19
00810198920055TekBrace SoloTheraMicro, LLCOWX2025-08-29
00810198920062TekBrace SoloTheraMicro, LLCOWX2025-08-29
05060267134271SIC GraftXIROS LTDOWX2025-08-07
05060267134493Infinity-Lock 3XIROS LTDOWX2025-08-07
05060267134509Infinity-Lock 5XIROS LTDOWX2025-08-07
00888867301931Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301962Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301986Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301948Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301955Arthrex®ARTHREX, INC.OWX2025-06-13
10888867301969Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301979Arthrex®ARTHREX, INC.OWX2025-06-13
10888867301983Arthrex®ARTHREX, INC.OWX2025-06-13
05060267134301AchilloCordPLUSXIROS LTDOWX2025-03-26
07649988202247FiberLocker InstrumentZuriMED Technologies AGOWX2025-02-10
05060267134295Poly-Tape 5 mm x 500 mmXIROS LTDOWX2024-10-10
00817337000241Integrity ImplantAnika Therapeutics, Inc.OWX2023-11-09
00817337000258Integrity Implant Anika Therapeutics, Inc.OWX2023-11-09
05060267133755Pitch-Patch 30 mm x 20 mmXIROS LTDOWX2023-10-05
05060267133762Pitch-Patch 35 mm x 25 mmXIROS LTDOWX2023-10-05
05060267131812Poly-Tape 30mm x 800mmXIROS LTDOWX2023-07-03
05060267132499Poly-Tape 5 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132505Poly-Tape 7 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132512Poly-Tape 10 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132529Poly-Tape 15 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132536Poly-Tape 20 mm x 800 mm XIROS LTDOWX2022-10-14