InterSpace Hip SPC0122
by Tecres
InterSpace Hip SPC0122 is a Class II device made by Tecres, cleared under FDA 510(k) K101356 on 20 Sep 2011 and listed in FDA GUDID since 12 Oct 2015 (UDI-DI 28031497000620), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number28031497000620 | Date12 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101356 | Date20 Sep 2011 | StatusActive |
Official records
- AccessGUDID record 28031497000620
- FDA 510(k) database K101356
Across registries
- FDA 510(k) K101356 decided 20 Sep 2011 Active
- FDA GUDID UDI-DI 28031497000620 listed 12 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K101356
- Listed FDA GUDID 28031497000620
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- InterSpace Hip
- Generic name
- Orthopaedic cement spacer
- Model / reference
- SPC0122
- Primary DI / UDI-DI
- 28031497000620
- 510(k) Number
- FDA product code
- MBB, KWL, KWY
- GMDN term
- Orthopaedic cement spacer
- Device class
- Class II
- Regulation number
- 888.3027, 888.3360, 888.3390
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 94 Millimeter