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Biosorb Otis

by S.B.M 10 variants

Ref P822365228Model Wedge for HTO (30 % TCP +/-5 %)

Biosorb Otis (P822365228) is a device classified as Class III in the EU and Class II in the US made by S.B.M, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-03760154001496), cleared under FDA 510(k) K071155 on 3 Jul 2007 and listed in FDA GUDID since 13 Oct 2015 (UDI-DI 03760154001496), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K071155

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154001496 Basic UDI-DI 03760154001496UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154001496 UDI-DI Date13 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK071155 Date3 Jul 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760154001496 registered 21 Oct 2026 Active
  • FDA 510(k) K071155 decided 3 Jul 2007 Active
  • FDA GUDID UDI-DI 03760154001496 listed 13 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K071155
  2. Listed FDA GUDID 03760154001496
  3. Registered EUDAMED B-03760154001496

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Otis® EUDAMED
Biosorb GUDID
Generic name
Synthetic bone graft
Model / Ref / Catalog
Wedge for HTO (30 % TCP +/-5 %), P822365228, OTIS
Primary DI / UDI-DI
03760154001496
Basic UDI-DI
B-03760154001496
510(k) Number
FDA product code
MQV
EMDN code
P900402 Resorbable filling and reconstruction devices
GMDN term
Synthetic bone graft
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3045
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Height — 9 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Wedge for HTO (30 % TCP +/-5 %)
P822365228
GUDID
OTIS
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Synthetic bone graft

Similar devices in this category

Other devices filed under RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)