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InterSpace Shoulder SPS0121

by Tecres

InterSpace Shoulder SPS0121 is a Class II device made by Tecres, cleared under FDA 510(k) K112983 on 12 Dec 2011 and listed in FDA GUDID since 8 Oct 2015 (UDI-DI 28031497000408), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K112983

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 Number28031497000408 UDI-DI Date8 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112983 Date12 Dec 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112983 decided 12 Dec 2011 Active
  • FDA GUDID UDI-DI 28031497000408 listed 8 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112983
  2. Listed FDA GUDID 28031497000408

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
InterSpace Shoulder
Generic name
Orthopaedic cement spacer
Model / reference
SPS0121
Primary DI / UDI-DI
28031497000408
510(k) Number
FDA product code
KWS, HSD
GMDN term
Orthopaedic cement spacer
Device class
Class II
Regulation number
888.3660, 888.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic cement spacer

Cleared under the same submission (K112983)

Other devices from Tecres

See all devices from Tecres →

Properties

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