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Sierra™

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Sierra™ FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Parallel Rod Connector, 3.5/3.5, Double FDA UDI
Model / Reference
50-0135 FDA UDI
Description
Parallel Rod Connector, 3.5/3.5, Double FDA UDI

Identifiers

Catalog Number
50-0135 FDA UDI
Primary DI / UDI-DI
10889981059040 FDA UDI
510(k) Number
K072729 FDA UDI
FDA Product Code
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

Category: Bone-screw internal spinal fixation system connector

Sierra™ by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K072729 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SeaSpine Orthopedics Corporation

Sources (1)

  • FDA UDI 9ae541af-33b6-435e-8736-63f3e6f053fe 37 fields · synced Jun 8, 2026