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Sign in to claim this brandAJU PHARM. CO., LTD.
US
Last updated May 30, 2026
What AJU PHARM. CO., LTD. makes
The company manufactures bioabsorbable and non-bioabsorbable tendon and ligament bone anchors, as well as bioabsorbable orthopaedic bone screws for surgical fixation. It also produces single-use arthroscopic access cannulas, fluted surgical drill bits, reusable drill guides and tap tools, and associated obturators for orthopaedic procedures.
These devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) and UDI registries. The company operates within the United States, adhering to applicable domestic regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AJU Pharm. Co., Ltd. manufacture?
AJU Pharm. Co., Ltd. specializes in orthopaedic surgical devices, including tendon and ligament bone anchors (both bioabsorbable and non-bioabsorbable), bioabsorbable orthopaedic bone screws, and reusable tools like surgical drill guides and bone taps. They also produce single-use items such as arthroscopic access cannulas and fluted surgical drill bits, designed for procedures like ligament repair or joint reconstruction. These devices are engineered to support fixation, access, and precision drilling in orthopaedic surgery.
Where is AJU Pharm. Co., Ltd. based, and does this affect its regulatory compliance?
AJU Pharm. Co., Ltd. is based in the United States, which means its devices must comply with FDA regulations. Since the company’s products fall under FDA classifications (Class I and Class II), they are subject to domestic submission requirements like the 510(k) pathway for premarket notifications and the Unique Device Identifier (UDI) system for traceability. Compliance ensures these devices meet U.S. safety and performance standards before use.
Which regulatory registries list AJU Pharm. Co., Ltd.’s devices, and why?
AJU Pharm. Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) pathway is used for Class II devices to demonstrate substantial equivalence to a predicate device, while the UDI system ensures standardized identification for tracking and traceability. These registries help healthcare providers and regulators verify device compliance and history, supporting safe clinical use.
How are AJU Pharm. Co., Ltd.’s devices classified under FDA regulations?
AJU Pharm. Co., Ltd.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls, while Class II devices—like certain bone anchors or arthroscopic tools—may need special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) submissions for Class II, ensuring appropriate oversight based on device risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ajupharm.co.kr
- —
- —
- [email protected]
- Phone
- +82226300700
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 963422810
Catalogue (59)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Joinix Cannula System | ACS60072a | FDA UDI | Class II | Active |
| Fixone Biocomposite Interference Screw | IAB-90025a | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | BAB-55002dh | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | BAB-45003ch | FDA UDI | Class II | Active |
| Fixone All Suture Anchor | FAM-7615802fg | FDA UDI | Class II | Active |
| Fixone All Suture Anchor | FAS-1652803jw | FDA UDI | Class II | Active |
| Joinix Cannula System | ACT82572b | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.SL-G300 | FDA UDI | Class I | Active |
| Fixone Biocomposite Anchor | BAN-55003b | FDA UDI | Class II | Active |
| Fixone Biocomposite Interference Screw | IAB-70028a | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | BAB-55003ch | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.B-Awl550ak | FDA UDI | Class I | Active |
| Fixone Instrument | Fixone.I.F-D/P | FDA UDI | Class I | Active |
| Fixone Biocomposite Anchor | KAB-55001da | FDA UDI | Class II | Active |
| Fixone All Suture Anchor | FAF-24615802ig | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | NAB-47502d | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.JF-D/G160S | FDA UDI | Class I | Active |
| Fixone Biocomposite Anchor | KAB-55001ca | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.B-A/T550a | FDA UDI | Class I | Active |
| Fixone Hybrid Anchor | KAPN-47501nc | FDA UDI | Class II | Active |
| Fixone Hybrid Anchor | KAPN-47501c | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.JF-D/B180 | FDA UDI | Class I | Active |
| Fixone Biocomposite Interference Screw | IAB-10025a | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.JF-D/G160 | FDA UDI | Class I | Active |
| Fixone Instrument | Fixone.I.F-G | FDA UDI | Class I | Active |
| Fixone Instrument | Fixone.I.S-D/G300 | FDA UDI | Class I | Active |
| Fixone Instrument | Fixone.I.B-Awl450ak | FDA UDI | Class I | Active |
| Fixone Instrument | Fixone.I.S-D/B300 | FDA UDI | Class I | Active |
| Fixone Instrument | Fixone.I.B-A/T450a | FDA UDI | Class I | Active |
| Fixone Hybrid Anchor | KAP-55001ca | FDA UDI | Class II | Active |
| Fixone Hybrid Anchor | KAP-47501ca | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | BAN-47503b | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | SAL-30002ni | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.I-Driver | FDA UDI | Class I | Active |
| Fixone Biocomposite Anchor | SAB-30002e | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | KAB-47501ca | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.SL-OB300 | FDA UDI | Class I | Active |
| Fixone Biocomposite Anchor | BAN-55002c | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | BAN-47502c | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.I-T8090 | FDA UDI | Class I | Active |
| Fixone Instrument | Fixone.I.JF-OB160 | FDA UDI | Class I | Active |
| Fixone Meniscal Repair | FMC-14665B | FDA UDI | Class II | Active |
| Fixone Meniscal Repair | FMC-14665d | FDA UDI | Class II | Active |
| Fixone Biocomposite Anchor | SAL-30002i | FDA UDI | Class II | Active |
| Fixone Hybrid Anchor | KAPN-55001c | FDA UDI | Class II | Active |
| Fixone Hybrid Anchor | KAPN-55001nc | FDA UDI | Class II | Active |
| Fixone Biocomposite Interference Screw | IAB-80025a | FDA UDI | Class II | Active |
| Fixone Biocomposite Interference Screw | IAB-70023a | FDA UDI | Class II | Active |
| Fixone Instrument | Fixone.I.SL-D300 | FDA UDI | Class I | Active |
| Fixone Biocomposite Anchor | K192484 | FDA 510(k) | Class II | Active |
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