Identity
- Trade Name
- CitreLock Tendon Fixation Lid FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Model / Reference
- 40-999-0003 FDA UDI
Identifiers
- Catalog Number
- 40-999-0003 FDA UDI
- Primary DI / UDI-DI
- 00810027270160 FDA UDI
- 510(k) Number
- K200725 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
CitreLock Tendon Fixation Lid by Acuitive Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
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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
- 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 |
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Manufacturer
- Manufacturer
- Acuitive Technologies
Sources (1)
- FDA UDI 60b4e21d-1921-4549-8ff3-39f094c6ba2a 35 fields · synced May 30, 2026