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Sierra™

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Sierra™ FDA UDI
Generic Name
Cannulated surgical drill bit, single-use FDA UDI
Device Name
Rod, 3.5 x 60mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system. FDA UDI
Model / Reference
50-6060 FDA UDI
Description
Rod, 3.5 x 60mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system. FDA UDI

Identifiers

Catalog Number
50-6060 FDA UDI
Primary DI / UDI-DI
10889981043094 FDA UDI
510(k) Number
K062934 FDA UDI
FDA Product Code
KWP FDA UDI
MNI FDA UDI
GMDN Term
Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Category: Cannulated surgical drill bit, single-use

The Sierra™ is a high-quality, advanced surgical drill bit designed for orthopedic procedures. This single-use cannulated surgical drill bit is used to provide stabilization of the spine during spinal fusion surgery, allowing for biological process of spinal fusion to occur. With its proprietary design and materials, this device offers superior stability and comfort, making it an ideal choice for surgeons and patients alike.

Similar devices

Also classified as Cannulated surgical drill bit, single-use.

Cleared under the same submission

K062934 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 f0692411-5f8c-4a9e-86cf-28288db9787b 37 fields · synced Jul 22, 2026