LUNA XD
GUDID 00840606166997
#3 SERRATED CUP CURETTE, ANGLED DOWN-BITING 60°
SPINAL ELEMENTS, INC.
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 00840606166997 |
| NIH Device Record Key | 00e744a3-fee5-4ce2-afb3-730214c2bb8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUNA XD |
| Version Model Number | IBS10017 |
| Company DUNS | 610712213 |
| Company Name | SPINAL ELEMENTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840606166997 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
[00840606166997]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-29 |
| Device Publish Date | 2021-04-21 |
On-Brand Devices [LUNA XD]
| 00840606166249 | FIXED T-HANDLE, SLIM, HUDSON, LARGE |
| 00840606165440 | 6MM STRAIGHT PITUITARY RONGEURS |
| 00840606165433 | 4MM CURVED PITUITARY RONGEURS |
| 00840606165426 | 4MM UP-BITING PITUITARY RONGEURS |
| 00840606165419 | 4MM STRAIGHT PITUITARY RONGEURS |
| 00840606165402 | 2MM STRAIGHT PITUITARY RONGEURS |
| 00840606165396 | 4MM KERRISON RONGEURS |
| 00840606165389 | 2MM KERRISON RONGEURS |
| 00840606165372 | 1/4"STRAIGHT OSTEOTOME |
| 00840606165334 | SLAP HAMMER |
| 00840606165327 | 5MM NERVE RETRACTOR, RIGHT ANGLED |
| 00840606165143 | 5MM NERVE RETRACTOR, BAYONETTED |
| 00840606165136 | ANNULOTOMY KNIFE, BAYONETTED |
| 00840606165099 | 3/8" STRAIGHT OSTEOTOME |
| 00840606165501 | 8MM WEDGE DISTRACTOR, LONG |
| 00840606165495 | 7MM WEDGE DISTRACTOR, LONG |
| 00840606165488 | 6MM WEDGE DISTRACTOR, LONG |
| 00840606165471 | 5MM WEDGE DISTRACTOR, LONG |
| 00840606165464 | 4MM WEDGE DISTRACTOR, LONG |
| 00840606165457 | 3MM WEDGE DISTRACTOR, LONG |
| 00840606165228 | 6MM STRAIGHT RASP, DOUBLE-SIDED, BAYONETTED |
| 00840606165211 | 6MM STRAIGHT TRIANGLE CURETTE, BAYONETTED |
| 00840606165204 | 9MM STRAIGHT RASP, DOUBLE-SIDED, BAYONETTED |
| 00840606165198 | 11MM STRAIGHT TRIANGLE CURETTE, BAYONETTED |
| 00840606165181 | #3 ANGLED LEFT CUP CURETTE, BAYONETTED |
| 00840606165174 | #3 ANGLED RIGHT CUP CURETTE, BAYONETTED |
| 00840606165167 | #3 ANGLED DOWN-BITING CUP CURETTE, BAYONETTED |
| 00840606165150 | #3 STRAIGHT CUP CURETTE, BAYONETTED |
| 00840606165129 | 10MM ROTARY SHAVER |
| 00840606165112 | 8MM ROTARY SHAVER |
| 00840606165105 | 6MM ROTARY SHAVER |
| 00840606167130 | ROTATING PADDLE SHAVERS, 15MM |
| 00840606167123 | ROTATING PADDLE SHAVERS, 14MM |
| 00840606167116 | ROTATING PADDLE SHAVERS, 13MM |
| 00840606167109 | ROTATING PADDLE SHAVERS, 12MM |
| 00840606167093 | ROTATING PADDLE SHAVERS, 11MM |
| 00840606167086 | ROTATING PADDLE SHAVERS, 10MM |
| 00840606167079 | ROTATING PADDLE SHAVERS, 9MM |
| 00840606167062 | ROTATING PADDLE SHAVERS, 8MM |
| 00840606167055 | ROTATING PADDLE SHAVERS, 7MM |
| 00840606167048 | ROTATING PADDLE SHAVERS, 6MM |
| 00840606167031 | SLOTTED MALLET, 325G |
| 00840606167024 | #3 SERRATED CUP CURETTE, UP-BITING 15° |
| 00840606167017 | #3 SERRATED CUP CURETTE, ANGLED LEFT 60° |
| 00840606167000 | #3 SERRATED CUP CURETTE, ANGLED RIGHT 60° |
| 00840606166997 | #3 SERRATED CUP CURETTE, ANGLED DOWN-BITING 60° |
| 00840606166980 | #3 SERRATED CUP CURETTE, DOWN-BITING 60° |
| 00840606166973 | #3 SERRATED CUP CURETTE, UP-BITING 60° |
| 00840606166966 | #3 SERRATED CUP CURETTE, STRAIGHT UP |
| 00840606166744 | 8MM NERVE RETRACTOR, RIGHT ANGLED |
Trademark Results [LUNA XD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUNA XD 90408363 not registered Live/Pending |
Spinal Elements, Inc. 2020-12-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.