Identity
- Trade Name
- 3.5 X 15.5mm Citrefix XPress System FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Model / Reference
- 70-810-3515 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810027270863 FDA UDI
- 510(k) Number
- K203334 FDA UDI
- FDA Product Code
- MAI FDA UDIMBI FDA UDIHXG FDA UDIHTW FDA UDIHXY FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI888.4540 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
Yes
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
Yes
FDA UDI
MR Safe FDA UDI
Category: Fluted surgical drill bit, single-useTendon/ligament bone anchor, bioabsorbableSurgical drill guide, single-useOrthopaedic inorganic implant inserter/extractor, single-use
3.5 X 15.5mm Citrefix XPress System by Acuitive Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203334 also covers:
- 2.9 X 12.5mm Citrefix XPress System — ACUITIVE TECHNOLOGIES
- 2.9 x 12.5mm Citrefix Implant — ACUITIVE TECHNOLOGIES
- 3.5 x 15.5mm Citrefix Implant — ACUITIVE TECHNOLOGIES
- 4.5 X 24mm Citrefix Implant — ACUITIVE TECHNOLOGIES
- 4.5 X 24mm Citrefix XPress System — ACUITIVE TECHNOLOGIES
- 5.5 X 24mm Citrefix Implant — ACUITIVE TECHNOLOGIES
- 5.5 X 24mm Citrefix XPress System — ACUITIVE TECHNOLOGIES
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 |
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Manufacturer
- Manufacturer
- Acuitive Technologies
Sources (1)
- FDA UDI 88b5d325-fdb4-4822-934c-a396b9153d7f 34 fields · synced May 30, 2026