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Pisces Spinal System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K203023

by Ortho Development Corporation

Identity

Trade Name
Pisces Spinal System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Modular Cannulated DL Pedicle Screw Diameter 8.5x45mm FDA UDI
Model / Reference
753-8545-20 FDA UDI
Description
Modular Cannulated DL Pedicle Screw Diameter 8.5x45mm FDA UDI

Identifiers

Primary DI / UDI-DI
00822409044122 FDA UDI
510(k) Number
K203023 FDA 510(k)FDA UDI
FDA Product Code
NKB FDA 510(k)FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 45 Millimeter FDA UDI
Outer Diameter — 8.5 Millimeter FDA UDI

Pisces Spinal System by Ortho Development Corporation — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ortho Development Corporation

Sources (2)

  • FDA 510(k) K203023 24 fields · synced Jun 18, 2026
  • FDA UDI 235d55f5-850e-40ce-81de-2561dbdfb0be 36 fields · synced May 27, 2026