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SpaceFlex Hip

by G21 S.R.L. Italy EUDAMEDGUDID

Ref G210.00.019, G210.00.020, G210.00.021, 900005 15 Product code KWLEMDN P090805

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08058964727220 Basic UDI-DIDate24 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08058964727220 UDI-DIDate4 Nov 2019ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Orthopaedic cement spacer mould
Model / Reference
G210.00.019, G210.00.020, G210.00.021, 900005 15
Primary DI / UDI-DI
08058964727220, 08058964727237, 08058964727244, 08058964726902
Basic UDI-DI
B-08058964727220, B-08058964727237, B-08058964727244, B-08058964726902
510(k) Number
FDA Product Code
KWL, KWY, MBB
EMDN Code
P090805 Hip prostheses spacers
GMDN Term
Orthopaedic cement spacer mould
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3360, 888.3390, 888.3027
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
IT-MF-000030085

Other devices from G-21 S.R.L.

See all devices from G-21 S.R.L. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Lot / Batch Number
  • Expiration Date
Other properties (17)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (5)

  • EUDAMED a4ec694a-abc9-47ea-9df5-f619ce8f9954 61 fields · synced 24 Oct 2026
  • EUDAMED 08058964727237|B-08058964727237 61 fields · synced 17 May 2026
  • EUDAMED 08058964727244|B-08058964727244 61 fields · synced 18 May 2026
  • EUDAMED 08058964726902|B-08058964726902 61 fields · synced 18 May 2026
  • FDA UDI 44326dfd-1478-4ef1-8309-3b060a1d2a5b 34 fields · synced 30 May 2026