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ComposiTCP™ Non-sliding BroadBand

by S.B.M 3 variants

Ref 110026114Model anchor + 2 sutures + screwdriver

ComposiTCP™ Non-sliding BroadBand (110026114) 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 7 Oct 2026 (Basic UDI-DI B-03760154007238), cleared under FDA 510(k) K180960 on 25 Jul 2018 and listed in FDA GUDID since 12 Jul 2019 (UDI-DI 03760154007238), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180960

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154007238 Basic UDI-DI 03760154007238UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154007238 UDI-DI Date12 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK180960 Date25 Jul 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760154007238 registered 7 Oct 2026 Active
  • FDA 510(k) K180960 decided 25 Jul 2018 Active
  • FDA GUDID UDI-DI 03760154007238 listed 12 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180960
  2. Listed FDA GUDID 03760154007238
  3. Registered EUDAMED B-03760154007238

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  • Withdrawn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
ComposiTCP EUDAMED
ComposiTCP™ GUDID
Generic name
Tendon/ligament bone anchor, bioabsorbable
Device name
implant for rotator cuff repair
Model / Ref / Catalog
anchor + 2 sutures + screwdriver, 110026114, Non-sliding BroadBand
Primary DI / UDI-DI
03760154007238
Basic UDI-DI
B-03760154007238
510(k) Number
FDA product code
MAI
EMDN code
P090199 Shoulder prostheses - other
GMDN term
Tendon/ligament bone anchor, bioabsorbable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Outer Diameter — 5.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
anchor + 2 sutures + screwdriver
110026114
GUDID
Non-sliding BroadBand
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: Tendon/ligament bone anchor, bioabsorbable

Cleared under the same submission (K180960)

and 4 more cleared under K180960

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES - OTHER.

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)