Altapore 1508032
by Apatech Ltd
Altapore 1508032 is a Class II device made by Apatech Ltd, cleared under FDA 510(k) K241564 on 2 Aug 2024 (1 earlier submission) and listed in FDA GUDID since 5 Nov 2020 (UDI-DI 00085412630731), 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 | FDA 510(k)SESE | NumberK241564 | Date2 Aug 2024 | StatusActive |
| United States | GUDID listing | Number00085412630731 | Date5 Nov 2020 | StatusListed |
Official records
- AccessGUDID record 00085412630731
- FDA 510(k) database K241564
- FDA 510(k) database K201464
Across registries
- FDA 510(k) K241564 decided 2 Aug 2024 Active
- FDA GUDID UDI-DI 00085412630731 listed 5 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K201464
- Listed FDA GUDID 00085412630731
- Cleared FDA 510(k) K241564
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Altapore
- Generic name
- Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
- Model / Ref / Catalog
- 1508032
- Description
- Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler
- Primary DI / UDI-DI
- 00085412630731
- FDA product code
- MQV
- GMDN term
- Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
- Device class
- Class II
- Regulation number
- 888.3045
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 7.5 Milliliter
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