Xpand Corpectomy Spacer
510(k) K050850
Xpand Corpectomy Spacer is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K050850 on 26 May 2005, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050850 | Date26 May 2005 | StatusActive |
Official records
- FDA 510(k) database K050850
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K050850
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| XPAND 116.001 | 116.001 | 00849044022216 | Height 29 mm; Width 32 mm; Depth 25 mm | On the market |
| XPAND 116.005 | 116.005 | 00849044022254 | Depth 25 mm; Width 32 mm; Height 46 mm | On the market |
| XPAND 116.006 | 116.006 | 00849044022261 | Depth 25 mm; Height 60 mm; Width 32 mm | On the market |
| XPAND 116.008 | 116.008 | 00849044022285 | Depth 25 mm; Width 32 mm; Height 57 mm | On the market |
| XPAND 116.009 | 116.009 | 00849044022292 | Depth 25 mm; Width 32 mm; Height 47 mm | On the market |
| XPAND 116.010 | 116.010 | 00849044022308 | Width 32 mm; Height 61 mm; Depth 25 mm | On the market |
| XPAND 116.011 | 116.011 | 00849044022315 | Width 32 mm; Height 47 mm; Depth 25 mm | On the market |
| XPAND 116.013 | 116.013 | 00849044022339 | Height 79 mm; Width 32 mm; Depth 25 mm | On the market |
| XPAND 116.014 | 116.014 | 00849044022346 | Height 33 mm; Depth 25 mm; Width 32 mm | On the market |
| XPAND 116.016 | 116.016 | 00849044022360 | Height 29 mm; Width 32 mm; Depth 25 mm | On the market |
| XPAND 116.018 | 116.018 | 00849044022384 | Height 41 mm; Depth 25 mm; Width 32 mm | On the market |
| XPAND 116.021 | 116.021 | 00849044022414 | Height 51 mm; Depth 25 mm; Width 32 mm | On the market |
| XPAND 116.022 | 116.022 | 00849044022421 | Height 29 mm; Depth 25 mm; Width 32 mm | On the market |
| XPAND 116.023 | 116.023 | 00849044022438 | Width 32 mm; Depth 25 mm; Height 29 mm | On the market |
| XPAND 116.024 | 116.024 | 00849044022445 | Depth 25 mm; Height 32 mm; Width 32 mm | On the market |
| XPAND 116.102 | 116.102 | 00849044022469 | Height 18 mm; Width 14 mm; Depth 12 mm | On the market |
| XPAND 116.105 | 116.105 | 00849044022490 | Width 14 mm; Depth 12 mm; Height 42 mm | On the market |
| XPAND 116.107 | 116.107 | 00849044022513 | Depth 12 mm; Width 14 mm; Height 15 mm | On the market |
| XPAND 116.111 | 116.111 | 00849044022551 | Depth 12 mm; Width 14 mm; Height 42 mm | On the market |
| XPAND 116.113 | 116.113 | 00849044022575 | Depth 12 mm; Height 56 mm; Width 14 mm | On the market |
| XPAND 116.114 | 116.114 | 00849044022582 | Depth 12 mm; Height 74 mm; Width 14 mm | On the market |
| XPAND 116.116 | 116.116 | 00849044022605 | Width 14 mm; Depth 12 mm; Height 74 mm | On the market |
| XPAND 116.118 | 116.118 | 00849044022629 | Depth 12 mm; Height 19 mm; Width 14 mm | On the market |
| XPAND 116.119 | 116.119 | 00849044022636 | Width 14 mm; Depth 12 mm; Height 29 mm | On the market |
| XPAND 116.120 | 116.120 | 00849044022643 | Width 14 mm; Depth 12 mm; Height 29 mm | On the market |
| XPAND 116.121 | 116.121 | 00849044022650 | Width 14 mm; Depth 12 mm; Height 15 mm | On the market |
| XPAND 116.124 | 116.124 | 00849044022681 | Width 14 mm; Height 18 mm; Depth 12 mm | On the market |
| XPAND 116.125 | 116.125 | 00849044022698 | Height 19 mm; Depth 12 mm; Width 14 mm | On the market |
| XPAND 116.201 | 116.201 | 00849044022711 | Height 24 mm; Width 23 mm; Depth 21 mm | On the market |
| XPAND 116.202 | 116.202 | 00849044022728 | Width 23 mm; Height 27 mm; Depth 21 mm | On the market |
| XPAND 116.204 | 116.204 | 00849044022742 | Width 23 mm; Depth 21 mm; Height 49 mm | On the market |
| XPAND 116.205 | 116.205 | 00849044022759 | Height 24 mm; Width 23 mm; Depth 21 mm | On the market |
| XPAND 116.206 | 116.206 | 00849044022766 | Height 27 mm; Width 23 mm; Depth 21 mm | On the market |
| XPAND 116.209 | 116.209 | 00849044022797 | Height 33 mm; Depth 21 mm; Width 23 mm | On the market |
| XPAND 116.211 | 116.211 | 00849044022810 | Width 23 mm; Height 43 mm; Depth 21 mm | On the market |
| XPAND 116.213 | 116.213 | 00849044022834 | Height 24 mm; Width 23 mm; Depth 21 mm | On the market |
| XPAND 116.217 | 116.217 | 00849044022872 | Width 23 mm; Height 43 mm; Depth 21 mm | On the market |
| XPAND 116.218 | 116.218 | 00849044022889 | Height 49 mm; Width 23 mm; Depth 21 mm | On the market |
| XPAND 116.221 | 116.221 | 00849044022919 | Height 24 mm; Width 23 mm; Depth 21 mm | On the market |
| XPAND 116.301 | 116.301 | 00849044022957 | Height 18 mm; Depth 21 mm; Width 23 mm | On the market |
| XPAND 116.302 | 116.302 | 00849044022964 | Width 23 mm; Depth 21 mm; Height 19 mm | On the market |
| XPAND 116.303 | 116.303 | 00849044022971 | Height 21 mm; Width 23 mm; Depth 21 mm | On the market |
| XPAND 116.304 | 116.304 | 00849044022988 | Width 23 mm; Height 18 mm; Depth 21 mm | On the market |
| XPAND 116.402 | 116.402 | 00849044023022 | Depth 25 mm; Width 32 mm; Height 26 mm | On the market |
| XPAND 116.403 | 116.403 | 00849044023039 | Width 32 mm; Height 29 mm; Depth 25 mm | On the market |
| XPAND 116.407 | 116.407 | 00849044023077 | Width 32 mm; Depth 25 mm; Height 26 mm | On the market |
| XPAND 116.408 | 116.408 | 00849044023084 | Width 32 mm; Height 29 mm; Depth 25 mm | On the market |
| XPAND 116.409 | 116.409 | 00849044023091 | Depth 25 mm; Height 41 mm; Width 32 mm | On the market |
| XPAND 116.411 | 116.411 | 00849044023114 | Height 36 mm; Width 32 mm; Depth 25 mm | On the market |
| XPAND 116.413 | 116.413 | 00849044023138 | Depth 25 mm; Width 32 mm; Height 26 mm | On the market |
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