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Curved Rod, 5.5 x 45

FDA UDI

Class II (US FDA UDI)

by Captiva Spine

Identity

Trade Name
Curved Rod, 5.5 x 45 FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Curved Rod, 5.5 x 45 FDA UDI
Model / Reference
2455-2045 FDA UDI
Description
Curved Rod, 5.5 x 45 FDA UDI

Identifiers

Primary DI / UDI-DI
M73924552045 FDA UDI
510(k) Number
K120292 FDA UDI
FDA Product Code
MNI FDA UDI
MNH 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
Not 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Curved Rod, 5.5 x 45 by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K120292 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Captiva Spine

Sources (1)

  • FDA UDI 05c089ee-539d-4c3e-b48d-b2e9903cd5f2 35 fields · synced May 31, 2026