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Orthopediatrics® Spica Table

by OrthoPediatrics Corp. 28 variants

Ref 03-1006-0204Model ORTHOPEDIATRICS® SPICA TABLE

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841132110062D Basic UDI-DI 00841132136232UDI-DIDate8 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132136232 UDI-DI Date15 Feb 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Orthopediatrics® Spica Table EUDAMED
Spica Table GUDID
Generic Name
Operating table patient positioning set, reusable
Device Name
OrthoPediatrics® Spica Table Devices
Model / Ref / Catalog
ORTHOPEDIATRICS® SPICA TABLE, 03-1006-0204
Primary DI / UDI-DI
00841132136232
Basic UDI-DI
0841132110062D
FDA Product Code
JEB
EMDN Code
L99 Surgical instruments, reusable - other
GMDN Term
Operating table patient positioning set, reusable
Device Class
Class I
Regulation Number
878.4950
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000001776
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No