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ComposiTCP™ Suture Anchor Punch Tap

by S.B.M 2 variants

Ref 110026112Model Punch tap

ComposiTCP™ Suture Anchor Punch Tap (110026112) is a device classified as Class I in the EU and Class II in the US made by S.B.M, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-03760154008280), cleared under FDA 510(k) K170868 on 30 Nov 2017 and listed in FDA GUDID since 13 Mar 2018 (UDI-DI 03760154008280), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170868

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154008280 Basic UDI-DI 03760154008280UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154008280 UDI-DI Date13 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170868 Date30 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760154008280 registered 4 Nov 2026 Active
  • FDA 510(k) K170868 decided 30 Nov 2017 Active
  • FDA GUDID UDI-DI 03760154008280 listed 13 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170868
  2. Listed FDA GUDID 03760154008280
  3. Registered EUDAMED B-03760154008280

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  • Withdrawn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
Bone tap, reusable
Device name
Shoulder instrument
Model / Ref / Catalog
Punch tap, 110026112, Suture Anchor Punch Tap
Primary DI / UDI-DI
03760154008280
Basic UDI-DI
B-03760154008280
510(k) Number
FDA product code
MAI
EMDN code
L098003 Orthopaedic and traumatological surgery taps, reusable
GMDN term
Bone tap, reusable
Device class
Class I 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

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Punch tap
110026112
GUDID
Suture Anchor Punch Tap
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 03760154008280: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I 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: Bone tap, reusable

Cleared under the same submission (K170868)

and 6 more cleared under K170868

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (18, all answered No)