Skip to content

PRECICE® Intramedullary Limb Lengthening System P8.5-50X230

by Nuvasive Specialized Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887517935724 UDI-DI Date3 Jan 2018ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PRECICE® Intramedullary Limb Lengthening System
Generic Name
Femur intramedullary nail
Model / Ref / Catalog
P8.5-50X230
Primary DI / UDI-DI
00887517935724
510(k) Number
FDA Product Code
HSB
GMDN Term
Femur intramedullary nail
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Outer Diameter — 8.5 Millimeter

Related devices

Category: Femur intramedullary nail

Cleared under the same submission (K172628)

Show all (12)

Other devices from Nuvasive Specialized Orthopedics, Inc.

See all devices from Nuvasive Specialized Orthopedics, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No