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Nebula Standard Offset Size 11 111-59-0011

by Signature Orthopaedics Pty Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09348215134624 UDI-DI Date20 Mar 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Nebula Standard Offset Size 11
Generic Name
Coated hip femur prosthesis, modular
Model / Reference
111-59-0011
Primary DI / UDI-DI
09348215134624
510(k) Number
FDA Product Code
MEH, OQI, LPH, OQG, KWZ, KWL, KWY, LZO
GMDN Term
Coated hip femur prosthesis, modular
Device Class
Class II
Regulation Number
888.3353, 888.3358, 888.3310, 888.3360, 888.3390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated hip femur prosthesis, modular

Cleared under the same submission (K243029)

Show all (12)

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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