Identity
- Trade Name
- 5 x 15mm CitreLock Xpress Implant Kit FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
- Model / Reference
- 70-812-0515 FDA UDI
Identifiers
- Catalog Number
- 70-812-0515 FDA UDI
- Primary DI / UDI-DI
- 00810027270313 FDA UDI
- 510(k) Number
- K200725 FDA UDI
- FDA Product Code
- HWC FDA UDIMAI FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Category: Tendon/ligament bone anchor, bioabsorbableOrthopaedic inorganic implant inserter/extractor, single-use
5 x 15mm CitreLock Xpress Implant Kit by Acuitive Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200725 also covers:
- 4 x 10mm CitreLock Implant — ACUITIVE TECHNOLOGIES
- 4 x 10mm CitreLock Xpress Implant Kit — ACUITIVE TECHNOLOGIES
- 5 x 10mm CitreLock Implant — ACUITIVE TECHNOLOGIES
- 5 x 15mm CitreLock Implant — ACUITIVE TECHNOLOGIES
- 6 x 15mm CitreLock Implant — ACUITIVE TECHNOLOGIES
- 6 x 15mm CitreLock Xpress Implant Kit — ACUITIVE TECHNOLOGIES
- 6 x 23mm CitreLock Implant — ACUITIVE TECHNOLOGIES
- 6 x 23mm CitreLock Xpress Implant Kit — ACUITIVE TECHNOLOGIES
- 7 x 15mm CitreLock Xpress Implant Kit — ACUITIVE TECHNOLOGIES
- 7 x 23mm CitreLock Implant — ACUITIVE TECHNOLOGIES
- 7 x 23mm CitreLock Xpress Implant Kit — ACUITIVE TECHNOLOGIES
- 7 x15mm CitreLock Implant — 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 5d059b31-e6a0-4e8e-a257-b57af2dbbc8c 35 fields · synced May 30, 2026