Artificial Shoulder Joint
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 06, 2024- Analysis ID
- 2403308ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220307-0025
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH IDS MEDICAL SYSTEMS VIỆT NAM
- Intended Use
- The SMR Surface Regeneration System is indicated to replace part or all of the initial shoulder in patients with mature bone, where the humeral head and neck have sufficient bone mass to support the prosthetic components. The surgical surface regeneration heads are indicated to replace part or all of the initial shoulder when the rotator cuff is intact or reparable. Specific indications include: • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Inflammatory degenerative joint diseases, such as rheumatoid arthritis; • Treatment of acute fractures of the humeral head where other fracture fixation techniques are not applicable; • Revision due to initial prosthesis failure (not applicable to the Subscapularis Preserving Technique; applicable only to the short SMR stem with non-cemented collar, if there is sufficient bone mass remaining); • Tear of the glenoid labrum (applicable only to the CTA head, not applicable to the Subscapularis Preserving Technique with the triangular group of muscles); • Degenerative joint disease, non-avascular necrosis: A1, A2 and B1 according to the Walch classification (applicable only to the SMR TT Hybrid Glenoid). The SMR Surface Regeneration Shoulder Joint is intended for use without cement.
- Registration Date
- Nov 06, 2024
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Access comprehensive regulatory information for Artificial Shoulder Joint in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403308ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH IDS MEDICAL SYSTEMS VIỆT NAM.
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