TiMesh®

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name: TiMesh® FDA UDI
Generic Name: Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name: SCREW 015051 SELF TAPPING 1.5X5MM 1 FDA UDI
Model / Reference: 015051 FDA UDI
Description: SCREW 015051 SELF TAPPING 1.5X5MM 1 FDA UDI

Identifiers

Primary DI / UDI-DI: 00885074228259 FDA UDI
510(k) Number: K062348 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 5.0 Millimeter FDA UDI
Width — 1.5 Millimeter FDA UDI

Category: Craniofacial bone screw, non-bioabsorbable

TiMesh® by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniofacial bone screw, non-bioabsorbable.

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LEVEL ONE CMF — KLS-Martin L.P. · Class II
MatrixMANDIBLE — Synthes · Class II
OsteoMed — Osteomed Corp. · Class II
LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II

Cleared under the same submission

K062348 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic PS Medical

Sources (1)

FDA UDI 6c41ed9e-aea8-4cb9-a42f-e61068469c79 36 fields · synced May 31, 2026