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InSpace™ 0132

by Ortho-Space Ltd

InSpace™ 0132 is a Class II device made by Ortho-Space Ltd, granted FDA De Novo DEN200039 on 12 Jul 2021 and listed in FDA GUDID since 1 Aug 2021 (UDI-DI 17290013396065), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

De Novo DEN200039

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17290013396065 UDI-DI Date1 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Direct NumberDEN200039 Date12 Jul 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA De Novo DEN200039 decided 12 Jul 2021 Active
  • FDA GUDID UDI-DI 17290013396065 listed 1 Aug 2021 Listed

Timeline

2 dated events

  1. Granted FDA De Novo DEN200039
  2. Listed FDA GUDID 17290013396065

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Specification

GUDID

Trade name
InSpace™
Generic name
Tendon spacer
Model / Ref / Catalog
0132
Primary DI / UDI-DI
17290013396065
De Novo Number
FDA product code
QPQ
GMDN term
Tendon spacer
Device class
Class II
Regulation number
888.3630
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Tendon spacer

Cleared under the same submission (DEN200039)

Other devices from Ortho-Space Ltd

See all devices from Ortho-Space Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)