Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
by Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 325 variants
Ref R.70042-13060, E.R.70082-05004, 10922-20018, 70549-04004, E.43062-09305, 40062-90380, 40532-13400, E.44012-09215, 70102-00042, E.40302-11240, 10942-10017, 21052-65050, E.44012-09255, 40652-20018, 40322-12380, 21072-40048, 11172-00005, 40572-00000, 11412-20008, R.70072-10002, 20362-45036, E.43062-10275, R.70063-00004, 47092-00055, E.43002-10405, 12042-20014, 11112-10008, R.70072-10007, 40492-10300, 40342-10220, 40372-00115, E.43002-09405, 20382-65115, 40532-14320, 21292-73060, R.70039-00013, R.70039-00017, 43062-12285, 43062-10295, 21072-40012, 21162-35022, R.70042-11060, 12042-10016, 21052-65060, 40492-08300, 10872-20010, 40552-64095, 40222-00022, R.70039-10017, 21162-35048, 10922-20012
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-8680941561772BL | Date23 Apr 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- REVISION KNEE PROSTHESIS STRAIGHT STEM Ø 13-60 mm (TI)REVISION KNEE PROSTHESIS TIBIA PLATO HALF WEDGE 5 mm SIZE 4 (TI)Locking Proximal Lateral Humeral Plate 18 Holes Left (Ti)TOTAL KNEE PROSTHESES TIBIAL INSERT (C/R) HYPERFLEX 70 / 15 mm (UHMWPE)INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø9X305 mm (TI)INTRAMEDULLARY FEMORAL NAIL 9 X 380 mm (TI)GFN MULTI-PURPOSE FEMORAL NAIL Ø 13 X 400 mm LEFT (TI)INTRAMEDULLARY COMPRESSION NAIL (ICN) HUMERUS Ø9X215mm (TI)ACETABULAR CUP CEMENTLESS PLASMA / POROUS COATED Ø 42 mm (Ti)CANNULATED INTRAMEDULLARY RETROGRADE FEMORAL NAIL 11 X 240 mm (TI)Locking Distal Lateral Fibula Plate 17 Holes Right (Ti)CANCELLOUS SCREW 32 mm THREADED 6.5 X 50 (TI)INTRAMEDULLARY COMPRESSION NAIL (ICN) HUMERUS Ø9X255 mm (TI)INTRAMEDULLARY LOCKING SCREW FOR NAIL Ø 2.0 X 18 mm (TI)CANNULATED PFN LONG NAIL 12 X 380 mm RIGHT (TI)CANCELLOUS SCREW 1/3 mm THREADED, 4.0 X 48 mm (TI)LOCKING LC DCP BROAD PLATE 4.5 mm 5 HOLES (TI)Femoral Nail Proximal Screw, Locking Screw (Ti)Locking Distal Posterior Humerus Plate 8 Holes Left (Ti)REVISION KNEE PROSTHESIS FEMUR POSTERIOR CONDYLE WEDGE 10 mm SIZE 2 (TI)CORTICAL SCREW 4.5 X 36 mm (TI)INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø10X275 mm (TI)Revision Knee Prosthesis Tibia Plato Size 4 (B) (Cocr)LAG COMPRESSION SCREW 55 mm (TI)INTRAMEDULLARY COMPRESSION NAIL (ICN) FEMUR Ø10X405 mm (TI)Locking Distal Radius Plate Volar Large 16 Holes Left (Ti)Locking Proximal Lateral Tibial L Plate 8 Holes Right (Ti)REVISION KNEE PROSTHESIS FEMUR POSTERIOR CONDYLE WEDGE 10 mm SIZE 7 (TI)GTN TIBIA NAIL Ø 10 X 300 mm (TI)PFNA PROXIMAL FEMUR NAIL Ø10X220 mm (TI)PFNA LAG SCREW 115 mm (TI)INTRAMEDULLARY COMPRESSION NAIL (ICN) FEMUR Ø9X405 mm (TI)CANCELLOUS SCREW 16 mm THREADED 6.5 X 115 (TI)GFN MULTI-PURPOSE FEMORAL NAIL Ø 14 X 320 mm LEFT (TI)LOCKING CANNULATED SCREW 16 mm THREADED 7.3 X 60 mm (TI)Revision Knee Prosthesis Tibia Insert Size A-13 (Uhmwpe)Revision Knee Prosthesis Tibia Insert Size A-17 (Uhmwpe)INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø12X285 mm (TI)INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø10X295 mm (TI)CANCELLOUS SCREW 1/2 mm THREADED, 4.0 X 12 mm (TI)LOCKING CANNULATED SCREW 3.5 X 22 mm (TI)REVISION KNEE PROSTHESIS STRAIGHT STEM Ø 11-60 mm (TI)Locking Distal Radius Plate Volar Large 16 Holes Right (Ti)CANCELLOUS SCREW 32 mm THREADED 6.5 X 60 (TI)GTN TIBIA NAIL Ø 8 X 300 mm (TI)Locking Olecranon Plate 10 Holes Left (Ti)FEMORAL NAIL CANNULATED PROXIMAL LOCKING SCREW FOR Ø 6.4 X 95 mm (TI)LOCKING SCREW FOR NAIL 22 mm (TI)Revision Knee Prosthesis Tibia Insert Size B-17 (Uhmwpe)LOCKING CANNULATED SCREW 3.5 X 48 mm (TI)Locking Proximal Lateral Humeral Plate 12 Holes Left (Ti)
- Model / Reference
- R.70042-13060, E.R.70082-05004, 10922-20018, 70549-04004, E.43062-09305, 40062-90380, 40532-13400, E.44012-09215, 70102-00042, E.40302-11240, 10942-10017, 21052-65050, E.44012-09255, 40652-20018, 40322-12380, 21072-40048, 11172-00005, 40572-00000, 11412-20008, R.70072-10002, 20362-45036, E.43062-10275, R.70063-00004, 47092-00055, E.43002-10405, 12042-20014, 11112-10008, R.70072-10007, 40492-10300, 40342-10220, 40372-00115, E.43002-09405, 20382-65115, 40532-14320, 21292-73060, R.70039-00013, R.70039-00017, 43062-12285, 43062-10295, 21072-40012, 21162-35022, R.70042-11060, 12042-10016, 21052-65060, 40492-08300, 10872-20010, 40552-64095, 40222-00022, R.70039-10017, 21162-35048, 10922-20012
- Primary DI / UDI-DI
- D-8680941561772BL, D-8680941566807CH, D-86804198214389U, D-8680941525095AD, D-8680941549398CL, D-8680941542900AN, D-8680419869690DC, D-8680941550097AF, D-8680419867498D4, D-86809415208619Z, D-8680419821698AQ, D-8680419856225BD, D-86809415501349U, D-86809415145019H, D-8680419833585B3, D-8680419856751C7, D-8680419828222AL, D-8680419887762DL, D-8680419835510AJ, D-8680941562922BN, D-868041982400298, D-8680941549473C9, D-8680941560904B6, D-8680941543426AN, D-8680941548766CL, D-8680941569280CJ, D-8680419826990BS, D-8680941563073AZ, D-8680419868259CP, D-8680419833868BJ, D-8680419840460A4, D-8680941548612BQ, D-8680419824767B7, D-8680419887946DY, D-8680419890014AY, D-8680941561147AP, D-8680941561161AH, D-8680941545789CB, D-8680941545574BL, D-8680419856577CF, D-8680419862011A7, D-8680941561710AW, D-8680941569228CG, D-8680419856249BT, D-8680419868075CB, D-86804198206469W, D-8680419870238B2, D-8680419889834E2, D-8680941561239AV, D-8680419862141AM, D-86804198213469N
- Basic UDI-DI
- B-8680941561772BL, B-8680941566807CH, B-86804198214389U, B-8680941525095AD, B-8680941549398CL, B-8680941542900AN, B-8680419869690DC, B-8680941550097AF, B-8680419867498D4, B-86809415208619Z, B-8680419821698AQ, B-8680419856225BD, B-86809415501349U, B-86809415145019H, B-8680419833585B3, B-8680419856751C7, B-8680419828222AL, B-8680419887762DL, B-8680419835510AJ, B-8680941562922BN, B-868041982400298, B-8680941549473C9, B-8680941560904B6, B-8680941543426AN, B-8680941548766CL, B-8680941569280CJ, B-8680419826990BS, B-8680941563073AZ, B-8680419868259CP, B-8680419833868BJ, B-8680419840460A4, B-8680941548612BQ, B-8680419824767B7, B-8680419887946DY, B-8680419890014AY, B-8680941561147AP, B-8680941561161AH, B-8680941545789CB, B-8680941545574BL, B-8680419856577CF, B-8680419862011A7, B-8680941561710AW, B-8680941569228CG, B-8680419856249BT, B-8680419868075CB, B-86804198206469W, B-8680419870238B2, B-8680419889834E2, B-8680941561239AV, B-8680419862141AM, B-86804198213469N
- EMDN Code
- P09090501, P09120599, P0909030101, P09120201, P090803010202, P09120699, P09098099, P09120601, P09120603
- Device Class
- Class IIIClass IIb
- EU market of registration
- TürkiyeGreece
Manufacturer details
- EUDAMED SRN
- TR-MF-000016470
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Properties
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No