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Polyaxial screw, w/o cannulation 7.5/45mm

FDA UDI

Class II (US FDA UDI)

by mahe medical gmbh

Identity

Trade Name
Polyaxial screw,w/o cannulation 7.5/45mm FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Polyaxial screw,w/o cannulation 7.5/45mm FDA UDI
Model / Reference
PSS11-17545 FDA UDI
Description
Polyaxial screw,w/o cannulation 7.5/45mm FDA UDI

Identifiers

Catalog Number
PSS11-17545 FDA UDI
Primary DI / UDI-DI
EMAHPSS11175450 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

Polyaxial screw, w/o cannulation 7.5/45mm by mahe medical gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
mahe medical gmbh

Sources (1)

  • FDA UDI 5eee733e-7287-4afe-99fa-a7e1dfb05748 35 fields · synced Jun 8, 2026