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InSitu Hip System 10-95-2001

by Nextstep Arthropedix

InSitu Hip System 10-95-2001 is a Class I device made by Nextstep Arthropedix, listed in FDA GUDID since 14 Aug 2023 (UDI-DI 00816127021503), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816127021503 UDI-DI Date14 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
InSitu Hip System
Generic name
Bone-resection orthopaedic reamer, reusable
Model / reference
10-95-2001
Primary DI / UDI-DI
00816127021503
FDA product code
LXH
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-resection orthopaedic reamer, reusable

Other devices from Nextstep Arthropedix

See all devices from Nextstep Arthropedix →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)