Identity
- Trade Name
- Citregen Tendon Sizing Kit FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Model / Reference
- 70-811-0001 FDA UDI
Identifiers
- Catalog Number
- 70-811-0001 FDA UDI
- Primary DI / UDI-DI
- 00810027270283 FDA UDI
- 510(k) Number
- K200725 FDA UDI
- FDA Product Code
- HWQ FDA UDIHWT FDA UDIHXI FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI888.4800 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: Orthopaedic bone wireWire/ligature passer, single-use
Citregen Tendon Sizing Kit by Acuitive Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wire/ligature passer, single-use.
- Arthrex® — Arthrex, Inc. · Class I
- Shuttle Pin — Trimed, INC. · Class I
- Shuttle Pin — Trimed, INC. · Class I
- LSSS — Lockdown Medical Ltd · Class I
- SuperCable® ISO-Elastic™ Cerclage System — Kinamed, Inc. · Class I
- Aesclepius Suture Cinch, Pack of 2 — AESCLEPIUS CORPORATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Shuttle Pin — Trimed, INC. · Class I
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
- 5 x 15mm CitreLock Xpress Implant Kit — 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
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acuitive Technologies
Sources (1)
- FDA UDI 8712189d-29ae-4c88-8240-7acc095d8728 35 fields · synced May 30, 2026