Identity
- Trade Name
- CastleLoc Pectus Bar System FDA UDI
- Generic Name
- Rib/rib cage internal fixation/bracing system bracing bar FDA UDI
- Device Name
- Stabilizer – Bridge 1 (type1) FDA UDI
- Model / Reference
- PB12-0010 FDA UDI
- Description
- Stabilizer – Bridge 1 (type1) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809986482112 FDA UDI
- 510(k) Number
- K243357 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Rib/rib cage internal fixation/bracing system bracing bar FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rib/rib cage internal fixation/bracing system bracing bar
CastleLoc Pectus Bar System by L&K Biomed Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rib/rib cage internal fixation/bracing system bracing bar.
- Pectus Bar Stabilizer, Low Profile — MedXpert GmbH · Class II
- Pectus BarLock™ Pin (Vpe 1) — MedXpert GmbH · Class II
- Pectus Bar Stabilizer, Standard — MedXpert GmbH · Class II
- Pectus Bar Stabilizer, Universal, S, 2 x Ø4 mm — MedXpert GmbH · Class II
- Pectus Bar, smooth ends, 406 mm — MedXpert GmbH · Class II
- Pectus Bar, smooth ends, 254 mm — MedXpert GmbH · Class II
- Pectus Bar, Universal 330 mm — MedXpert GmbH · Class II
- Pectus Ribas Bar Stabilizer, Low Profile — MedXpert GmbH · Class II
Cleared under the same submission
K243357 also covers:
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
- CastleLoc Pectus Bar System — L&K BIOMED CO. , LTD.
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
- L&K Biomed Co. , Ltd.
Sources (1)
- FDA UDI 108e6265-507b-4f4e-b0cc-1e6516f10f61 34 fields · synced May 30, 2026