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PRECICE Intramedullary Limb Lengthening System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K170346

by Nuvasive Specialized Orthopedics, Inc.

Identity

Trade Name
PRECICE® Intramedullary Limb Lengthening System FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
4.5x50mm Locking Screw, Fully Threaded FDA UDI
Model / Reference
TSA4.5-050 FDA UDI
Description
4.5x50mm Locking Screw, Fully Threaded FDA UDI

Identifiers

Catalog Number
TSA4.5-050 FDA UDI
Primary DI / UDI-DI
00887517936073 FDA UDI
510(k) Number
K170346 FDA 510(k)FDA UDI
FDA Product Code
HSB FDA 510(k)FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3020 FDA 510(k)
Regulation Number
888.3020 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

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

PRECICE Intramedullary Limb Lengthening System by Nuvasive Specialized Orthopedics, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nuvasive Specialized Orthopedics, Inc.

Sources (2)

  • FDA 510(k) K170346 24 fields · synced Jun 18, 2026
  • FDA UDI 0ad0b073-9856-4283-913f-626afb747267 36 fields · synced May 27, 2026