← Back to catalogue

Paramount IBF

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Paramount IBF FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
Fixed Trial; 27x7 (05-3517) FDA UDI
Model / Reference
29-20-2707 FDA UDI
Description
Fixed Trial; 27x7 (05-3517) FDA UDI

Identifiers

Catalog Number
29-20-2707 FDA UDI
Primary DI / UDI-DI
10889981041205 FDA UDI
510(k) Number
K103228 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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: Spinal implant trial

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

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K103228 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
SeaSpine Orthopedics Corporation

Sources (1)

  • FDA UDI 3c69b42e-bc87-4496-a09e-58cba6cc4aa4 37 fields · synced Jun 8, 2026