Identity
- Trade Name
- ACIS FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- ACIS IMPLANT-STERILE CONVEX/LARGE-10MM HEIGHT FDA UDI
- Model / Reference
- 08.843.510S FDA UDI
- Description
- ACIS IMPLANT-STERILE CONVEX/LARGE-10MM HEIGHT FDA UDI
Identifiers
- Catalog Number
- 08843510S FDA UDI
- Primary DI / UDI-DI
- 10705034762487 FDA UDI
- 510(k) Number
- K120275 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Polymeric spinal interbody fusion cage
Acis by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal interbody fusion cage.
- L-Box® — Innovasis, Inc. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- S-LIFT® — SPINEFRONTIER, INC. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
- Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Cleared under the same submission
K120275 also covers:
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — SYNTHES (U.S.A.) LP
- ACIS — Synthes
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synthes (u.s.a.) Lp
Sources (1)
- FDA UDI 2df50df6-5828-4cee-a861-269ce1bce372 36 fields · synced May 30, 2026