DJO Surgical
Altivate Anatomic AG, Pegged Glenoid SZ50, HW-7 Right, Eplus
2manufacturers in China registered for this device type
85catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | PAO |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K213387 |
| Record published | 2022-11-11 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 521-09-450 | In distribution | |
| 804-07-381 | In distribution | |
| 804-07-150 | In distribution | |
| 521-07-246 | In distribution | |
| 804-07-001 | In distribution | |
| 804-07-146 | In distribution | |
| 804-09-043 | In distribution | |
| 520-10-000 | In distribution | |
| 521-01-154 | In distribution | |
| 521-01-250 | In distribution | |
| 521-09-550 | In distribution | |
| 804-07-008 | In distribution | |
| 804-07-014 | In distribution | |
| 804-07-018 | In distribution | |
| 804-09-046 | In distribution | |
| 804-07-136 | In distribution | |
| 804-09-027 | In distribution | |
| 804-99-125 | In distribution | |
| 521-09-346 | In distribution | |
| 520-42-216 | In distribution | |
| 521-01-138 | In distribution | |
| 521-09-146 | In distribution | |
| 804-07-124 | In distribution | |
| 804-07-016 | In distribution | |
| 804-09-028 | In distribution | |
| 804-07-254 | In distribution | |
| 521-09-646 | In distribution | |
| 804-07-038 | In distribution | |
| 804-07-002 | In distribution | |
| 804-07-073 | In distribution | |
| 804-07-075 | In distribution | |
| 804-07-246 | In distribution | |
| 520-40-214 | In distribution | |
| 520-16-000 | In distribution | |
| 521-01-238 | In distribution | |
| 804-50-220 | In distribution | |
| 804-07-074 | In distribution | |
| 804-99-128 | In distribution | |
| 521-09-746 | In distribution | |
| 804-07-540 | In distribution | |
| 804-07-129 | In distribution | |
| 520-50-318 | In distribution | |
| 804-07-005 | In distribution | |
| 804-07-072 | In distribution | |
| 521-01-146 | In distribution | |
| 804-54-218 | In distribution | |
| 521-09-350 | In distribution | |
| 804-07-042 | In distribution | |
| 521-01-142 | In distribution | |
| 520-54-318 | In distribution | |
| 804-07-149 | In distribution | |
| 521-09-846 | In distribution | |
| 521-09-850 | In distribution | |
| 520-40-216 | In distribution | |
| 804-07-210 | In distribution | |
| 521-01-246 | In distribution | |
| 804-40-214 | In distribution | |
| 804-07-140 | In distribution | |
| 804-07-099 | In distribution | |
| 804-07-147 | In distribution | |
| 804-50-218 | In distribution | |
| 521-09-142 | In distribution | |
| 804-42-218 | In distribution | |
| 521-01-242 | In distribution | |
| 804-09-026 | In distribution | |
| 521-01-254 | In distribution | |
| 804-07-142 | In distribution | |
| 804-09-017 | In distribution | |
| 520-54-220 | In distribution | |
| 521-09-342 | In distribution | |
| 804-56-222 | In distribution | |
| 521-01-150 | In distribution | |
| 804-09-050 | In distribution | |
| 520-01-150 | In distribution | |
| 521-09-354 | In distribution | |
| 804-07-127 | In distribution | |
| 521-09-742 | In distribution | |
| 520-54-320 | In distribution | |
| 520-14-000 | In distribution | |
| 520-07-246 | In distribution | |
| 804-07-071 | In distribution | |
| 804-07-003 | In distribution | |
| 804-99-126 | In distribution | |
| 521-09-242 | In distribution | |
| 521-09-642 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perform™ Humeral System | Tornier Inc. | 76 |
| Comprehensive® Reverse Shoulder | Biomet Orthopedics | 68 |
| Link Embrace Shoulder System | Waldemar Link GmbH & Co. KG | 64 |
| Anatomical Shoulder™ Domelock® | Zimmer, Inc. | 43 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 38 |
| Link Embrace Shoulder System Line Extension | Waldemar Link GmbH & Co. KG | 32 |
| Inhance | Depuy (Ireland) | 31 |
| Tornier Perform Humeral System | Tornier Inc. | 17 |
| Comprehensive Instrumentation | Biomet Orthopedics | 16 |
| Embrace Shoulder System | Waldemar Link GmbH & Co. KG | 13 |
| Maestro™ Total Wrist | Biomet Orthopedics | 13 |
| Comprehensive® | Zimmer, Inc. | 11 |
Showing 12 of 29. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2021-06-28 | Class II | Process change control | Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery. | |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 92 units |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 92 units |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 92 units |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 92 units |
| Encore Medical, L.P. | 510(k) number | 2018-01-29 | Class II | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the i | 93 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.